Transcutaneous electrostimulator and methods for electric stimulation

ABSTRACT

An electrostimulation device comprising an electrode coupler configured as an earbud, the earbud shaped to form fit inside an ear canal of a human ear and composed of a pliable material that conforms to the ear canal when inserted therein, the pliable material forming at least two electrostimulation electrodes, each electrostimulation electrode conductively connected to a conductive lead adapted to receive a nerve electrostimulation signal, and the earbud adapted to transmit the nerve electrostimulation signal through the electrostimulation electrodes from the conductive leads to tissue within the ear canal when disposed therein.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is:

-   -   A continuation of a continuation U.S. patent application Ser.        No. 15/676,525, filed on Aug. 14, 2017, now U.S. Pat. No.        10,279,178, which is a continuation of U.S. patent application        Ser. No. 14/738,156, filed on Jun. 12, 2015, now U.S. Pat. No.        9,782,584, which application claims priority to U.S. Provisional        Application Ser. No. 62/011,985, filed Jun. 13, 2014, and        62/121,759, filed Feb. 27, 2015,        the entire disclosures of which are hereby incorporated by        reference herein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

FIELD OF THE INVENTION

The present invention lies in the field of electrical stimulationdevices. The present disclosure relates to methods of electricalstimulation of anatomic structures such as nerves, blood vessels,muscles, connective tissue, glands, individual organs, and organ systemsand devices that accomplish such stimulation using modulated electriccurrent applied directly or indirectly to tissue through external(non-invasive) or minimally invasive measures. In particular, thepresent disclosure relates to methods and devices that usetranscutaneous and percutaneous methods of stimulating nerves to causean array of therapeutic benefits, including those dependent upon wherethe stimulation is directed.

BACKGROUND OF THE INVENTION

It is known that the use of electric current to stimulate nerves andother anatomic structures can have positive therapeutic benefits. Thealteration of nerve activity through the delivery of electricalstimulation has been defined as neuromodulation or neurostimulation,which will be used interchangeably herein along with electrostimulation.One significant use is for control of pain. Prior to such uses, for manydecades, only medications were available. Neuromodulation devices beganwith implantable systems and moved to transcutaneous ones.

Historically, neuromodulation devices have most effectively accomplishedtherapeutic results by invasive measures. More specifically, the patienthas an electrode or coil surgically implanted directly onto the nervebeing targeted for stimulation and also has a signal generatorsurgically implanted under the skin. The signal generator is connectedto the stimulation electrode and passes current to the electrode.Medtronic, for example, developed a line of Deep Brain Stimulation (DBS)implants under the names Soletra® and Kinetra®, but they are no longersold. Some of these implants that are currently being sold use the tradename Activa® and mitigate symptoms of movement disorders, such asParkinson's Disease. These devices are implanted typically in patientswho are not able to use drugs for treatment.

Another system includes both implanted and external devices. In such aconfiguration, the patient has an electrode or coil surgically implanteddirectly onto the nerve being targeted for stimulation, and a signalgenerator separate from the electrode or coil is used to stimulatetranscutaneously the coil site by placing an active electrode on theskin in proximity to the implant. The powered signal generator passeselectromagnetic radiation or magnetic flux to, thereby, excite thepassive coil and induce it to emit its own electromagnetic emission.These systems employ induction measures for nerve stimulation, referredto as IMNS.

One type of neuromodulation using these implanted devices is vagus nervestimulation, a procedure that stimulates the vagus nerve with electricalimpulses. The vagus nerve (Cranial Nerve X) originates from thebrainstem as two separate nerves, which travel down the neck and chestand coalesce into one nerve with multiple branches that innervate organsin the thorax and abdomen. Vagus nerve stimulation can be used to treatepilepsy when other treatments have not worked adequately, for example.Vagus nerve stimulation has also been used as a treatment fordepression, and is being studied to treat other conditions such asmultiple sclerosis, migraine, weight loss, motion disorders, insomnia,management of pain, obesity, and Alzheimer's disease, to name a few.Historically, with vagus nerve stimulation, a stimulation device issurgically implanted at or about the vagus nerve and a signal generatoris surgically implanted under the skin, for example, near the claviclein the chest. A wire is threaded under the skin connecting the signalgenerator to the stimulation device at the vagus nerve. When activated,the signal generator sends electrical signals along the vagus nerve,which can either travel to the brainstem and have therapeutic effects onthe brain, travel down the vagus to affect various end-organs that aresupplied by this nerve, block physiologic nerves signals traveling alongthe vagus, or send signals simultaneously to the brain and to one ormore end-organs normally supplied by the vagus or to the brain only.

Electrostimulation can be used on any nerve or organ to have varioustherapeutic benefits. Directing modulated current to any cranial nervecould be used to affect the brain due to their natural anatomicconnection to the brainstem. For example, electrostimulation of thetrigeminal nerve or its branches may be able to block the perception ofpain of the head and face or mitigate these symptoms by causingendorphin release from the electrical signal that travels up to thebrain.

Cyberonics. Inc., sells a set of vagus nerve stimulators, each being animplantable device. They are sold under the trade names AspireHC™,Pulse™, and Demipulse™. Cyberonics received FDA approval for treatmentof epilepsy with their implants in 1997. Any implantable device carriesthe risks associated with anesthesia such as stroke and death, as wellas the risk of damage to vital structures surrounding the vagus andvocal cord paralysis, and the risk of infection at the surgical site. Ifthe device were to break or need to be adjusted, another surgery wouldbe required. Additionally, batteries that power the implanted generatorsfor these devices eventually wear down and must be replaced, requiringsurgery with associated risks for each generator change.

Another implanted device uses induction as a means to send a signal toan implanted device that is surgically placed on the vagus nerve. Aremovable collar is considered the device charger and is worn around thepatient's neck. Therapy is planned and programmed from a portableelectronic tablet. With such a device, the risks of surgery, as listedabove, still exist, in addition to the unsightly and cumbersome natureof a dog-collar style necklace.

Less invasive devices that exist use transcutaneous needle arrays. Oneexample of such a system is disclosed in U.S. Patent Publication No.2013/0150923 to Schnetz et al., and is sold by Biegler GmbH under thetrade name P-STIM®. A significant drawback of such systems is that theneedle electrodes break the skin, causing pain and the consequentpatient aversion, as well as an increasing risk of infection.

Non-invasive devices that are as or more effective would be desirable,for example, one that is utilized transcutaneously. Some devices employVagus Nerve Stimulation (VNS) transcutaneously in an attempt toreproduce the effects of implantable devices. For example, electroCoredeveloped a transcutaneous VNS device that looks like a stun-gun and isplaced on the neck over the vagus nerve. When activated, the deviceprovides electric stimulation to the neck when a patient feels the onsetof a seizure, electroCore's device is sold under the name gammaCore®.Due to the depth of the vagus nerve at that treatment location, suchdevices place a large electrical signal directly to the carotid arterywhen in use. Patients experience significant intolerance to such highlevels of electrical energy, as well as incur the possibility of closingthe artery, or dislodging plaque or a clot, if sufficient pressure isapplied over the treatment period. Additionally, it is known thatelectrical energy supplied to blood vessels can cause vasoconstriction.Thus, there is the dangerous possibility that the physical pressureexerted on the carotid could be enhanced by the electrical energy andshut the artery during treatment. In addition, significantly morecurrent is needed to traverse more interposed tissue, which isaccompanied with an increase in discomfort and can adversely affectother structures.

In contrast to the electroCore device, Cerbomed GmbH developed atranscutaneous VNS device under the name NEMOS®. The cell-phone-likecontroller connects to a non-adjustable earpiece that places twoelectrodes on the skin of the concha of the ear at two specific points.The earpiece serves as scaffolding that retains the position of theelectrodes and maintains constant contact forces of the electrodesagainst the skin of the target area within the concha of the ear. Theearpiece is retained with an “earbud-like” component that resides in theear canal inferiorly and under the “conchal ridge” superiorly. Retentionis dependent upon constant vertical spring forces that have to besubstantially strong enough to avoid movement of the apparatus. Theforce required to accomplish this is poorly tolerated over the prolongedrequired treatment periods because of the very thin skin of the outerear canal that the device is contacting, as well as the high degree ofsensitivity of the ear in this location. Such apparatuses in or aboutthe ear canal can impair hearing and negate the ability to use earphonesfor simultaneously listening of music. Additionally, the superiorretention point of the apparatus has a very thin skin, has minimalsubcutaneous “padding,” and is very non-compliant. Further, the surfacearea of contact of the retention device is limited in comparison to theforce required to retain the device, making the retention forces veryconcentrated and painful. The limited surface area contact causes highresistance, poor signal transmission, and increased pain. If the springforce was reduced to gain comfort, the earpiece would no longer beretained well and the electrode contact against the skin would becomesuboptimal or lost completely. Further, the superior and inferioranchoring points only lend to placing the electrodes at a specificlocation on the ear. This location may not be ideal for the therapeuticbenefit that such devices are intended to have. Therefore, the Cerbomedearpiece design does not lend itself to electrode placement at any otheranatomic locations about the ear. This apparatus is not resistant tomotion from routine human activity, such as walking quickly, running,collision with others and other objects, such as tree branches, crowds,wind, etc. Furthermore, the cord interfacing with the earpiece isdisposed of inferiorly and applies a downward force not only due to itsown weight but also when it gets caught or snagged on other objects. Thevertically grounded retention elements of the earpiece submit to theseforces and easily dislodge and subsequently disrupt proper contact ordislodge the necessary electrode interfacing with the skin.

Transcutaneous VNS uses the fact that the auricular branch of the vagusnerve (ABVN) supplies the skin of the concha in the human ear. TheNEMOS® generator applies electrical signals that are known in the art tothese two points. To overcome the resistance of the skin, this deviceprovides a very high level of energy that patients find difficult totolerate.

Another neuromodulation device for treatment of migraines takes the formof a headband and is sold by Cefaly-Technology, Inc. It is known thatmost headaches and migraines involve the trigeminal nerve. Its superiorbranch (supra-orbital) ends at the exit of the eye socket, underneaththe skin of the forehead. The Cefaly® headband connects to an adhesiveelectrode on the forehead. Through the electrode, the headband generatesmodulated electrical signals to stimulate the nerve endings of thetrigeminal nerve. Neuromodulation of the trigeminal nerve with Cefaly®helps reduce the frequency of migraine attacks. Efficacy of this devicerelies on maintaining proper contact to the skin during the entiretreatment duration and this is why the Cefaly® headband has significantnegative characteristics. The adequacy of maintaining electrical contactis very inconsistent and can vary based on the storage temperature ofthe electrode, the ambient temperature during application and use, thestability over time of the adhesive, relative humidity, skin thickness,skin oil levels, thickness of the underlying tissue, and potentialallergies to the substances within the adhesive. Also, the surface areaof the electrode is large, and resides on the forehead, making itunsightly, hot, and visually disruptive in certain locations such as theworkplace. Electrode removal can be painful as it strips underlying hairfrom the forehead. It is also cumbersome to apply a large adhesivebandage to one's own forehead and then be required to interface it witha generator as a multistep process. Finally, the device causes painfulmuscle contractions during use.

Current transcutaneous devices have not achieved good results for amultitude of reasons. First, current transmitted through the skin inorder to target an anatomic structure inside the body results in poorsignal strength to the target structure, poor localization of the targetstructure, and difficulty with signal transmission through the barrierof the skin and surrounding structures. Further, the high current hascollateral physiological effects to the surrounding non-targetedstructures. In addition, the degree of user coupler apposition to theskin is not maintained as a constant by present devices. This leads tovariation in impedance, which can adversely affect the degree oftransmission of the electromagnetic signal through the skin and,therefore, change the effectiveness of the signal in reaching the targetstructure. Moreover, maintenance of position at the location where theuser coupler is in contact to the external portion of the body has beena challenge due to variability of adhesives that adhere to skin and dueto discomfort of any devices that use strong springs or other mechanicalmeasures to maintain position. Additionally, fixation of the usercouplers that are secured secondarily to a structure remote from thetargeted skin interface location frequently lose their indexing due tobody motion and environmental contact. Loss of position on the skin bythe user coupler leads to the signal not being maintained on thetargeted internal structure, which adversely leads to ineffectiveness ofthe device. Furthermore, optimal locations at which stimulator usercouplers are recommended to be placed on the body surface are constantlychanging due to ongoing and evolving scientific research, thus makingobsolete user couplers that are designed only for a specific anatomiclocation. For systems that do not include a coupler, the user thenbecomes the coupling mechanism for the device, requiring steady hands tohold the device in a precise location to deliver the electrical signalto the desired underlying nerve structure throughout the duration of thetherapy.

User couplers of prior art neuromodulation devices and systems are notscalable to differing anatomies, require anatomies to be similar and/orconsistent, are not universal, do not maintain consistent and adequatecontact during daily activities, are unsightly, and are uncomfortable,and, when used about the ear, the prior art devices obstruct theauditory canal, are dependent upon obstructing the ear canal, andpreclude other auditory canal systems. With regard to the generatorelements of the prior art, they are not modulated or subject to externalinput, they are not synchronized with audio signals, and there are nofeatures to improve patient tolerance.

As can be seen, there is a need for systems and methods that provide anexternal, transcutaneous stimulator that maintains constant signaltransmission to the desired target, maintains electrodes at constantpressure and constant location for maximum efficacy, maintains positionof the user coupler on the body's interface location, and can bemodified easily to place electrodes at alternate interface locationswithout the need for changing device hardware.

It is well known that effectiveness of central nervous system (CNS)stimulation by sending electrical signals through the cranial,peripheral, or central nerves that are remote from the brain has beendemonstrated to treat various conditions such as epilepsy, depression,obesity, systemic inflammatory disorders, depression, sleep disorders,tinnitus, poor concentration, attention deficit disorders, heartdisease, arrhythmias, pain, and chronic pain, to name a few. Studieshave shown that effectiveness, as well as effectiveness for any givendisease or disorder, relates to the type of electrical signal generated(i.e., wave type/wave geometry, pulse width, dwell time, using pulsebursts, pulse duration, power, and patterns of administration of therapysuch as varying the amplitude of the current with or without variationsof some or all of the aforementioned parameters). A certain minimalpower threshold must be met to have a therapeutic benefit. As an upperpower threshold has not been established, it is well accepted that thereexists a “therapeutic range” of power that, on the low end, is theminimal power requirement to have any documentable therapeutic benefit.Increasing the power of the electronic signal above that therapeuticthreshold appears to have a greater benefit. The problem facingadvancing neuromodulation devices and methods is whether or not anindividual patient can tolerate the discomfort associated with thedelivery of a signal delivered at the power necessary to maximizetherapeutic benefit.

Due to the inconvenience of the application process of currenttranscutaneous neuromodulation devices and the inability to delivertherapy in a discrete way, users may choose to delay therapy until theyhave privacy and a dedicated amount of time for the treatment. Thisadditionally limits access to non-pharmacologic therapies that can treata multitude of chronic diseases, symptoms, and conditions.

It would be beneficial to provide systems and methods for allowing apatient to tolerate uncomfortable electronic signals delivered. Thus, aneed exists to overcome the problems with the prior art systems,designs, and processes as discussed above.

SUMMARY OF THE INVENTION

The invention provides systems and methods of electrostimulation thatovercome the hereinafore-mentioned disadvantages of the heretofore-knowndevices and methods of this general type and that accomplishelectrostimulation using modulated electric current applied directly orindirectly to human or animal anatomic targets through external(non-invasive) measures. In particular, the invention providesneuromodulation methods and devices by transcutaneously stimulatinganatomic targets to cause an array of therapeutic benefits depending onwhere the stimulation is directed. Various embodiments described hereinprovide electrostimulation at areas on the same side of the cranium, forexample, a pair of electrodes on the left or right side of the user'shead. Other embodiments can have electrodes placed on both sides of theuser's head but each respective electrode pair (or set) is only on oneside of the user's head. Finally, further embodiments can place the twoor more poles of a respective electrode pair or set on opposing sides ofthe user's head to deliver trans-cranial electrical stimulation.

There are additional advantages to transcutaneous measures that canconsistently, reliably, and universally deliver electrical signals forneuromodulation. One benefit provided by such transcutaneous measuresincludes instances where surgical implantation is impractical and/orcould not be predicted as a future need, such as pain mitigation for aninjured soldier, for example. In this circumstance, it is advantageousto be able to effectively connect electrodes to a soldier who is on thebattlefield with ease, reliability, and resistance to environmentalconditions, especially motion, and have the electrical signal bewell-tolerated by the subject and be consistently effective.Furthermore, the known positive effects that VNS has on mood elevationand enhanced concentration are effects that may be beneficial insituations that are not otherwise anticipated or require onlyintermittent therapy rather than the long-term therapy, such as providedby an implantable device. An example of this benefit could be understoodin the military, in general, because keeping mood, morale, andconcentration up is either more or less difficult depending on thesituation. For example, if a sniper just lost a fellow soldier or friendto an improvised explosive device, it may be difficult for that soldierto have the will or concentration to continue to discharge his/herduties as effectively as before. Having a device available that can beinterfaced quickly to that soldier, which not only will enhance his/hermood but increase concentration when the need arises to take an accurateshot at the enemy, is clearly advantageous. Other soldiers may havefluctuations in mood or concentration that can mitigated on an “asneeded” basis with a transcutaneous device.

One exemplary system and method herein utilizes a non-implanted signalgenerator connected (by wire or wirelessly) to a user coupler located onthe user's ear. As used herein, a user coupler, a patient coupler, anelectrode coupler, a user coupling device, or a device coupler all aredevices that place the electrodes adjacent the tissue to be electricallystimulated. In one exemplary embodiment, the user coupler placeselectrodes adjacent the auricular branch of the vagus nerve. In otherembodiments, the user coupler places electrodes adjacent to thetrigeminal nerve. Various advantages of the user couplers describedherein is that they are able to be used on varying overall ear anatomiesby taking advantage of various anatomical features including consistentanatomical features that are universal across a large portion of thepopulation, they are able to maintain consistent and adequate contactduring daily activities, they have a progressive look, they arecomfortable, and they are not dependent on occluding the auditory canalto allow other auditory canal systems (e.g., speakers for music) tofunction simultaneously.

Each of the prior art attempts to retain a user coupler have failedeither because it was designed to fit only one particular anatomicallocation and the progression of the technology made such a designobsolete or the retention device was just too uncomfortable for dailyuse or was designed for specific anatomic geometries that are quitevariable causing poor fit, poor retention, and poor contact in a largeportion of the population. In contrast, the user coupler configurationsdescribed herein are comfortable and can be used in the future even withimproved or different theories of use created. For example, asdiscoveries are made demonstrating that electrically stimulating new ordifferent points on or in proximity to the ear have increased efficacyor new benefits, it would be advantageous to use the same couplingmeasures to serve as a universal fixation allowing electrode contactwith any location on or near the ear with minor modification to theelectrode “extensions” or “booms.”

The user couplers, therefore, are independent of future research in thefield of electrode placement for neuromodulation. In the future, otherpoints may be identified as beneficial and, therefore, the user couplerscan be modified to target such other points. The structure of the earthat is targeted by exemplary embodiments of the device and methodsdescribed herein maximize retention to place the electrode user couplerin a strategic location, for example, to access all areas of the conchaof the ear and its surrounding structures with use of electrode booms orto access the ear canal. In exemplary embodiments, the electrodelocations are radially disbursed from a strategically located fixationpoint on the helix of the ear to facilitate excellent electrode contactin all potential target locations of the ear and surrounding structures.

The various configurations of the user couplers utilize either or bothof form-fitting and force-fitting connectors. A form-locking orform-fitting connection is one that connects two elements together dueto the shape of the elements themselves, as opposed to a force-lockingconnection, which locks the elements together by force external to theelements. In exemplary embodiments of the user couplers describedherein, a form-fitting clip follows anatomical structures of themid-helix or the ear canal that are substantially similar over vastpatient populations. In addition to such form-fitting structures,force-fitting structures provide a connection adjacent the electrodelocations that uses a mechanical or magnetic force to retain the usercoupler in place. One example is a pair of attractive magnets or amagnet-ferrous pair. The form-fitting and force-fitting embodiments canbe used together if desired in a particular application.

Other embodiments include a positioning and retention structure thatserves to maintain the user interface members and electrodes aboutspecific areas of the target anatomy, the target anatomy being pointswhere compression and/or electrical stimulation is intended to betargeted for a desired effect. Anatomical structures targeted with thesystems and methods described herein include a nerve, a series ofnerves, a bundle of nerves, blood vessels, muscular structures, and/ororgans. Some of the targeted nerves include all of the cranial andfacial nerves including, but not limited to, peripheral, central,sensory, motor, sensorimotor, and autonomic nerves and all of theirbranches, in particular, the vagus nerve, the trigeminal nerve, theauricular nerve, the occipital nerve, the auriculotemporal nerve, andthe trochlear nerve. In particular, embodiments herein, the trigeminalor vagus nerves are used. This is not to be understood as limited tothese nerves and it is to be understood as being equally interchangeablewith any cranial nerve, its branches, or blood vessels of the head orneck. Some of the targeted arteries include all of the cranial andfacial arteries including, but not limited to, the temporal, auricular,maxillary, occipital, and external carotid arteries and all of theirbranches. As used herein, a facial artery is meant to include the arterythat is coursing anterior to the tragus.

Critical areas of the systems and methods described herein directlycontact the user. There is one contacting member that connects the usercouplers containing electrodes so that the connection directs thecontact points and maintains the contact points for consistent signaldelivery. This connecting structure may generate dynamic and staticforces and/or torques ideally suited to maintain position and pressureof the apparatus about specific points of the human anatomy. In oneexemplary embodiment, the contacting member is a headband or a halo-likedevice that contains two user couplers interfacing with the ear canalsbilaterally and making contact with a cutaneously accessible portion ofthe vagus nerve. User couplers may also contain speakers with removablyattachable ear interface points that contain electrodes on one or bothuser couplers. The speaker component contains an electrical interfacepoint that allows electrode to be interfaced with a speaker component. Aremovably attachable component may have characteristics likemalleability for comfort or may contain no electrodes at all. The halomay contain rigid, semi-rigid, malleable, spring-like or stretchablematerial and may contain hinges with passive, ratchet-like, frictional,spring loaded, or magnetic hinge points to size the halo properly toindividuals with different head geometries, ear positions, and ear canalgeometries. The halo provides varying degrees of inward force to achieveand maintain adequate coaptation of the electrodes to the targetstructure, in this case, the ear canal. The halo may have telescopingcomponents that adjust in length or circumference of one or more partsof the structure to optimize fit and maintain contact between electrodemember and target organ for signal delivery. Frames that contain contactpoints are connected to other contact points through a common structure.This structure is customizable in length, angulation, and orientation tooptimize contact between the electrodes and the target structure as wellas a position for the duration of therapy. Some contact points may bejust for indexing and not for signal delivery. Contact points may or maynot contain electrodes. In addition, contact points may contain speakersand have disposable tips.

One exemplary embodiment of the signal generator delivers a specificelectromagnetic signal at a predetermined or variable current,frequency, and impulse rate and duration through a conduit that directsthe signal to a location remote from the generator to at least one usercoupler, which user coupler includes an electrode that serves as theelectrically positive contact point. Additionally, there is a least oneother electrode serving as the ground or electrically negative pointthat tracks through the conduit and back to the generator to completethe circuit. This configuration is not to be understood as limited tothe specific orientation described. In such embodiments, it is to beunderstood that, where multiple electrodes are used, polarity can beswitched at any time. In an exemplary embodiment, polarity can beswitched rapidly so that one electrode delivering current will not bemore uncomfortable than another, which could occur if the polarity ofthe electrodes always remained the same.

In exemplary embodiments, at least one of the electrodes contains amagnet and the other of the electrodes contains ferrous material or anoppositely charged magnet allowing the electrodes to be in reciprocalpositions on or about the skin such that the target structure to bestimulated is within the electromagnetic field generated by the signalgenerator. The magnetic user couplers disclosed serve as improvementsover present non-invasive, transcutaneous devices because each usercoupler includes two oppositely charged magnets (or magneticallyattractive materials) with integrated electrodes that are included ineach separate circuit that is conveying a transcutaneous energy emissionto the user. All electrodes mentioned herein can be of either polarity,as the generator can deliver alternating polarity. The magneticelectrodes are placed in reciprocal locations with respect to the user'ssurface anatomy, overlying a site that contains the structure to betargeted. Targeted structures may be a nerve, a series of nerves, abundle of nerves, blood vessels, muscular structures, and/or organs.Using electrodes integral to magnetic couplers results in an improvedease of placement with minimal training. The placement onto an anatomicsite is easily and precisely reproducible, allows for tissue compressionto reduce signal impedance, and resists movement of the electrodes offof their intended location due to constant magnetic retention forces.

Wind, rain, moisture, environmental contact, and user motion are factorsthat can cause electrodes to be moved inadvertently off their intendedlocation on the body, thus making the electrodes no longer an effectivestimulating device for the target location. The systems and methodsdescribed herein secure such electrodes in a manner to resist andprevent inadvertent movement due to any environmental influence. Oneexemplary method for delivering electromagnetic neural stimulation to aperson that addresses such factors comprises placing a user couplerhaving a positive electrode onto the target skin location and placing anegative (ground) electrode in the reciprocal position where a positionof both electrodes is maintained by the magnetic field of the twomagnets or a magnet and a ferrous material. After tissue compressionbetween the magnets is maximized, which occurs after a relatively shortperiod of time, impedance of the circuit is maintained because themagnetic field is constant. With pressure and distance at the electrodeinterface point maintained for a time consistent with therapy duration,the impedance remains substantially constant and ensures a consistentand predictable dose of electromagnetic signal at the target structure.Due to the maintained magnetic forces and the tissue compression andindentation, the user coupler resists straying from its originalposition, which movement may arise from sweat, user activity, orinadvertent environmental contact. If, however, the user coupler(s) didstray from its/their prescribed location, they can be easilyrepositioned by the user merely by placing the electrodes back onto thearea of visual skin compression, resulting in an instantaneousrestoration of compressive forces without the electrodes enduring anydecrement of forces and, therefore, maintaining the original impedanceand signal at the target structure.

In yet another aspect, multiple user couplers containing oppositelycharged electrodes emanate from the electrostimulation conduit, therebyallowing multiple electromagnetic signals to be transmitted through theskin to target one or more structures. This configuration allows thegenerator to power multiple pairs of electrodes to stimulate multipleanatomic locations selectively or simultaneously. If new or differentanatomic locations are discovered to be useful for the treatment ofdifferent ailments, this user coupler system can be placed easily ontodifferent external anatomic locations to maximize the device'stherapeutic benefit. Parallel or sequential therapies can also beadministered, i.e., both nerve stimulation and vasoconstriction or onethen the other, in one therapeutic period. All of the systems andmethods described herein with regard to electrostimulation of nerves arealso applicable for vasoconstriction or vasodilation treatments.

Other exemplary embodiments include a generator that sends a signal toone or more user couplers including one or more electrode points orpairs, each electrode delivering a distinct and independently adjustablesignal. Once one or more of the user couplers are connected to the bodysurface, the generator uses a sensing circuit to determine theelectrical properties of the target stimulation area such as impedance,resistance, capacitance, inductance, and any version of an equivalentcircuit such as RC, LC, and LRC. For example, the generator uses asensing circuit to determine the impedance at the electrode-skin surfaceinterface site. Once the generator determines the impedance level, thegenerator increases power delivered to the specific electrode orelectrodes that have an impedance level deemed too high based upon apre-programmed software algorithm. In users with electrode impedancelevels that are too low, the generator may, conversely, individuallylower power to the individual electrode or electrodes to achieve propersignal strength delivered to the targeted structure. In otherembodiments where multiple electrodes are present, the generator cansend no signal through the high-resistance electrodes and only sendsignals through electrodes where the resistance is acceptable. Thegenerator may also give a visual or audible output to the user if theeffectiveness of the signal cannot be mitigated by generatoradjustments. In these instances, the user may need to tighten,reposition, or add conductive gel in order to achieve proper signaltransmission. In the case of embodiments with multiple user couplers,each electrode pair, or each individual electrode in the case of acommon ground, will remain constant or individually be givenprogressively increasing power based on the individual impedance of eachelectrode. This allows the proper signal strength to be delivered to thetarget structure or structures in circumstances where increasedimpedance is registered by the impedance circuit contained within thegenerator. Levels of electrical properties may occur in individuals withvariations in thickness or character of their skin or with skincontaminants, moisture level, or general tissue thickness related togenetics, adipose content, amount of circulating blood volume,electrolyte levels in the serum, muscle size, moisture content, as wellas environmental factors such as rain, amount of compression imparted onthe skin by the magnetic retention forces, and exogenous conductive ornon-conductive materials such as dielectric compounds or exogenoustopically applied substances such as cosmetics or pharmaceuticals.

In another exemplary embodiment, systems and methods include usercouplers that have multiple, integrated electrodes that use a common orindividual grounding points. In such an embodiment, the “array” ofelectrodes is applied to the body surface as one unit. The arraycomprises multiple electrodes that are positioned in a predeterminedgeometry so that the electrodes come in contact with the targeted bodysurface location in a predictable, predetermined geometry. This isadvantageous in situations where it is desirable and most effective tostimulate a target structure with multiple electrodes positioned atseparate sites. Application of the user coupler including electrodearrays can be more efficient, reproducible, and accurate during itsapplication as opposed to placing multiple, individual electrodes to aspecific body surface that is in direct proximity or “signal proximity”to the organ being targeted by the signal. Other advantages of havingthe electrode array is the ability to sweep the signal among the variouselectrodes in different patterns, which increases user tolerance becausethere is not a continuous signal at fixed locations, and may have atreatment benefit by covering a broader area. Further embodiments ofgenerators configured to function with such arrays may include measuresfor determining electrical properties at the distinct locations of theelectrodes contained in the array and that respond by adjusting thesignal strength to an increasing or decreasing level to maximize thesignal's strength to the structure being targeted. Additionally, inputsderived from a plurality of user data may serve to modify whichindividual electrodes the generator inputs a greater or lesser signal.For example, if the generator is sending signals to a electrode array,or to multiple, individual electrodes, user response to effectiveness oftherapy may cause the generator to increase the signal to one or moreelectrodes, decrease to one or other electrodes, or even stop sending asignal completely to one or more electrodes to optimize treatment effectto the structure being targeted. The user may be prompted by a visual oraudible queue, for example, to input whether the user is experiencingproper effectiveness for any given therapy. If the user is inputtinguser interface data consistent with inappropriate effectiveness, thegenerator may change the signal strength or character at one or moreelectrode sites. In addition to the described user tolerance/comfortfeatures, the user coupler may contain a mechanical vibration devicethat transmits vibrations to the target location. Vibration on sensorysurfaces is known to distract a user from sensing pain and sometimescauses numbness. As such, the systems and methods described herein canbe augmented with a vibration system that administers vibrations orcompression independently or in synchronization with electrostimulationor inputs from devices such as audio.

As an additional feature of this feedback embodiment, the generator canbe provided with measures to respond to user input to optimizeeffectiveness of treatment and the generator and/or user couplers canmeasure and optimize electrode signals by having sensors integral orseparate from the user couplers to measure at least one or more of heartrate, respiratory rate, blood pressure skin/tissue moisture levels,oxygen saturation, motion, head position, cardiac output and venouspressure, and/or to perform an electro-cardiogram and/or anelectro-encephalogram and/or electromyography (EMG) and/or electrodermalactivity (EDA), or the electrodes can sense and/or measure suchparameters. The generator contains electronics and algorithms to measurethese physiologic parameters and, in turn, adjust the signals throughone or more of the electrodes that the generator is driving to optimizethe response to treatment.

In another exemplary embodiment, the generator device includes anability to change various qualities of the signal being generated. Thesequalities include number of signals transmitted (in embodiments withmultiple pairs of electrodes), which pairs of electrodes are to beactive (sent signals or off), amperage, voltage, amplitude, frequency,pulse duration, pulse type, and modulation type. The changes areaccomplished by using an adjustment device and by confirming user inputsby audible or visual outputs.

Other exemplary embodiments include a user surge button that allows theuser to receive a higher dose of stimulation emission to mitigatesymptoms that may “break-through” a lower level of constant,pre-programmed emissions. For example, with a user whose treatment forchronic back pain is auricular transcutaneous neural stimulation, theuser may have adequate pain control throughout the day at apredetermined generator setting, but, when lifting a heavy object, theuser experiences a heightened level of pain (i.e., breakthrough pain).At the moment the breakthrough pain becomes apparent, the user depressesthe user surge button to cause the generator to send an increased levelof signal through the conduit, with subsequent increased stimulation ofthe target structure, thereby mitigating the user's breakthrough pain.This can apply to seizures as well if the user is cognizant of an aura.

In other exemplary embodiments, the software, circuit, or “chip” thatdetermines device functionality (i.e., number of signal types, power,amplitude, frequency and pulse duration, selectability between usercouplers) can be removably replaced with routines or chips having otherfunctionality or can be reprogrammable at the factory, or through theuse of an app where the device having the app communicates with thepresent systems or the device and can be integrated into the deviceitself. In an exemplary chip configuration, the chip can be removed andreplaced into a specific socket or slot, or can be integrated into asealed or partially sealed battery pack that contains the chip, wherethe act of simply removing an existing battery pack and replacing itwith a new one having the same or different chip can instantaneouslychange or maintain device functionality. This configuration reducesmanufacturing costs as well as reduces consumer costs as it is no longernecessary to produce distinctly different generator units with differentfunctionality or require the consumer to replace the entire device toalter its functionality if that is desirable or indicated. The chip alsocan allow the same device to have expanded applications.

With the foregoing and other objects in view, there is provided, anelectrostimulation device comprising a hand-held electrostimulationgenerator receiving an input music signal and providing at an output anerve electrostimulation signal modulated by the input music signal, anelectronic signal conduit having at least two conductive leadsconductively connected to the output of the electrostimulationgenerator, and an electrode coupler comprising an earbud. The earbud isshaped to form fit inside an ear canal of a human ear and is composed ofa pliable material that conforms to the ear canal when inserted therein,the pliable material forming at least two electrostimulation electrodesconductively connected to a respective one of the at least twoconductive leads of the electronic signal conduit to receive the nerveelectrostimulation signal and transmitting the nerve electrostimulationsignal to at least two different, electrically conductive exteriorsurface portions of the pliable material and transcutaneously applyingthe nerve electrostimulation signal from the at least two conductiveleads to tissue within the ear canal when disposed therein.

With the objects in view, there is also provided an electrostimulationdevice comprising an audio source outputting a music signal, a hand-heldelectrostimulation generator receiving the music signal and providing atan output a nerve electrostimulation signal modulated by the musicsignal, an electronic signal conduit conductively connected to theoutput of the electrostimulation generator, and an electrode couplercomprising an earbud. The earbud has at least one audio speakercommunicatively connected to the audio source and receiving the audiosignals for output into the ear canal when worn, is shaped to form fitinside an ear canal of a human ear, is composed of a pliable materialthat conforms to the ear canal when inserted therein, the pliablematerial forming at least two electrostimulation electrodes conductivelyconnected to the electronic signal conduit to receive the nerveelectrostimulation signal and transmitting the nerve electrostimulationsignal to at least two different, electrically conductive exteriorsurface portions of the pliable material and transcutaneous applying thenerve electrostimulation signal to the tissue within the ear canal whendisposed therein, and supplies the nerve electrostimulation signal whilethe music signal is output from the at least one audio speaker.

With the objects in view, there is also provided an electrostimulationdevice to be connected to an audio source supplying a music signal, thedevice comprising a hand-held electrostimulation generator receiving themusic signal and providing at an output a nerve electrostimulationsignal modulated by the music signal, an electronic signal conduithaving at least two conductive leads conductively connected to theoutput of the electrostimulation generator, and an electrode couplercomprising and earbud and at least one audio speaker within the earbud.The earbud is shaped to form fit inside an ear canal of a human ear andis composed of a pliable material that conforms to the ear canal wheninserted therein, the pliable material forming at least twoelectrostimulation electrodes conductively connected to a respective oneof the at least two conductive leads of the electronic signal conduit toreceive the nerve electrostimulation signal and transmitting the nerveelectrostimulation signal to at least two different, electricallyconductive exterior surface portions of the pliable material andtranscutaneously applying the nerve electrostimulation signal from theat least two conductive leads to tissue within the ear canal whendisposed therein. The at least one audio speaker receives the musicsignal for output into the ear canal when the electrode coupler is worn.The electrostimulation generator supplies the nerve electrostimulationsignal while the music signal is output.

In accordance with a further feature, the input music signal is at leastone of a recorded music signal, a transmitted music signal and anambient signal obtained from the environment surrounding theelectrostimulation generator.

In accordance with an added feature, the electrostimulation generatorcomprises a modulation drive circuit into which the input music signalis received, the modulation drive circuit creating the output nerveelectrostimulation signal modulated dependent upon the input musicsignal.

In accordance with an additional feature, there is provided a mobilemusic supply device generating the input music signal and a generatorcoupler removably attaching the electrostimulation generator to themusic supply device.

In accordance with yet another feature, the earbud has a speakerassembly and the electronic signal conduit comprises a speaker conduitconductively connected to the speaker assembly and having a standardaudio jack shaped to be inserted into a standard audio output to receivetherefrom the input music signal and an electrostimulation conduitcomprising the at least two conductive leads to conductively connect themusic-modulated, nerve electrostimulation signal to a respective one ofthe at least two electrostimulation electrodes.

In accordance with yet a further feature, the earbud has a speakerassembly having at least one speaker, the electrostimulation generatorwirelessly transmits the nerve electrostimulation signal, and theelectrode coupler has a receiver receiving the nerve electrostimulationsignal, receiving the input music signal, conductively connected to theat least two electrostimulation electrodes to thereby provide nerveelectrostimulation to the at least two electrostimulation electrodes,and conductively connected to the speaker assembly to thereby providethe input music signal to the at least one speaker of the speakerassembly.

In accordance with yet an added feature, there is provided an audiosource outputting the input music signal, the electrode couplercomprising at least one audio speaker communicatively connected to theaudio source through the electronic signal conduit and receiving theinput music signal for output into the ear canal when the electrodecoupler is worn, the electrostimulation generator sending the nerveelectrostimulation signal to the electrode coupler while the input musicsignal is output by the at least one audio speaker.

In accordance with yet an additional feature, the audio source is one ofgenerating the input music signal from within the electrostimulationgenerator and separate from the electrostimulation generator andgenerating the input music signal externally from the electrostimulationgenerator.

In accordance with again another feature, the nerve electrostimulationsignal is a Vagus nerve electrostimulation signal.

In accordance with again a further feature, the electronic signalconduit has at least two conductive leads conductively connected to theoutput of the electrostimulation generator and the at least twoelectrostimulation electrodes are conductively connected to a respectiveone of the at least two conductive leads of the electronic signalconduit to receive the nerve electrostimulation signal.

In accordance with again an added feature, the audio source is a mobilemusic supply device and which further comprises a generator couplerremovably attaching the electrostimulation generator to the music supplydevice.

In accordance with again an additional feature, the audio source has astandard audio output, the at least one audio speaker is within theearbud, and the electronic signal conduit comprises a speaker conduitconductively connected to the at least one audio speaker and having astandard audio jack shaped to be inserted into the standard audio outputto receive therefrom the music signal and an electrostimulation conduitconductively connecting the music-modulated, nerve electrostimulationsignal to a respective one of the at least two electrostimulationelectrodes.

In accordance with still another feature, the electrostimulationgenerator is one of wirelessly connected to the audio source anddirectly connected to the audio source.

In accordance with a concomitant feature, the at least one audio speakeris one of wirelessly connected to the audio source and directlyconnected to the audio source.

Although the invention is illustrated and described herein as embodiedin systems and methods of transcutaneous electronic tissue stimulation,it is, nevertheless, not intended to be limited to the details shownbecause various modifications and structural changes may be made thereinwithout departing from the spirit of the invention and within the scopeand range of equivalents of the claims. Additionally, well-knownelements of exemplary embodiments of the invention will not be describedin detail or will be omitted so as not to obscure the relevant detailsof the invention.

Additional advantages and other features characteristic of the presentinvention will be set forth in the detailed description that follows andmay be apparent from the detailed description or may be learned bypractice of exemplary embodiments of the invention. Still otheradvantages of the invention may be realized by any of theinstrumentalities, methods, or combinations particularly pointed out inthe claims.

Other features that are considered as characteristic for the inventionare set forth in the appended claims. As required, detailed embodimentsof the present invention are disclosed herein; however, it is to beunderstood that the disclosed embodiments are merely exemplary of theinvention, which can be embodied in various forms. Therefore, specificstructural and functional details disclosed herein are not to beinterpreted as limiting, but merely as a basis for the claims and as arepresentative basis for teaching one of ordinary skill in the art tovariously employ the present invention in virtually any appropriatelydetailed structure. Further, the terms and phrases used herein are notintended to be limiting; but rather, to provide an understandabledescription of the invention. While the specification concludes withclaims defining the features of the invention that are regarded asnovel, it is believed that the invention will be better understood froma consideration of the following description in conjunction with thedrawing figures, in which like reference numerals are carried forward.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, where like reference numerals refer toidentical or functionally similar elements throughout the separateviews, which are not true to scale, and which, together with thedetailed description below, are incorporated in and form part of thespecification, serve to illustrate further various embodiments and toexplain various principles and advantages all in accordance with thepresent invention. Advantages of embodiments of the present inventionwill be apparent from the following detailed description of theexemplary embodiments thereof, which description should be considered inconjunction with the accompanying drawings in which:

FIG. 1 is a diagrammatic representation of an electrostimulator with onepair of user couplers for application to one body surface site;

FIG. 2 is a diagrammatic representation of the device in FIG. 1 with itssingle pair of user couplers applied to a user target area about theear,

FIG. 3 is a fragmentary illustration of a right human ear with anatomyindications;

FIG. 4 is a fragmentary, side perspective view of the ear with exemplaryembodiments of transcutaneous vagus nerve stimulation devices;

FIG. 5 is a fragmentary, rear perspective view of the ear of FIG. 4;

FIG. 6 is a fragmentary, lateral cross-sectional view of an upperportion the ear of FIG. 4 viewed from below;

FIG. 7 is a fragmentary, bottom perspective view of the ear of FIG. 4;

FIG. 8 is a fragmentary, side perspective and vertically cross-sectionalview of the ear of FIG. 4 with an exemplary embodiment of atranscutaneous vagus nerve stimulation device;

FIG. 9 is a front elevational view of an exemplary embodiment of a vagusnerve stimulation generator and control device;

FIG. 10 is a rear perspective view of a transcutaneous vagus nervestimulation system with an electrode application device in a dockedstate;

FIG. 11 is a perspective view of the system of FIG. 10 from in front ofa right side thereof;

FIG. 12 is a fragmentary, perspective view of the electrode applicationdevice of FIG. 10 clipped onto a left ear of a user;

FIG. 13 is a perspective view of the system of FIG. 10 from in front ofa right side thereof;

FIG. 14 is a fragmentary, perspective and laterally cross-sectional viewof the electrode application device of FIG. 12 viewed from above theuser with the application device in a docked and implanting state of theelectrodes;

FIG. 15 is a fragmentary, perspective and laterally cross-sectional viewof the electrode application device of FIG. 12 viewed from above theuser with the application device in an undocked state of the electrodespost-implantation;

FIG. 16 is a perspective view of an exemplary embodiment of aform-fitting electrode application device;

FIG. 17 is a fragmentary, diagrammatic view of a human left ear with theform-fitting electrode application device of FIG. 16 installed thereon;

FIG. 18 is a fragmentary, horizontally cross-sectional view of theelectrode application device of FIG. 16 installed on a human left ear,

FIG. 19 is a fragmentary, diagrammatic view of a human left ear withrespective nerve target locations;

FIG. 20 is a fragmentary, diagrammatic view of the form-fittingelectrode application device of FIG. 16 installed on an ear andindications of vagus nerve stimulation locations;

FIG. 21 is a fragmentary, diagrammatic view of the form-fittingelectrode application device of FIG. 16 installed on an ear anddiagrammatic representations of electrode booms to vagus nervestimulation locations;

FIG. 22 is a fragmentary, perspective view of the form-fitting electrodeof FIG. 16 on a left ear viewed from the below the rear of the ear;

FIG. 23 is a fragmentary, perspective view of the form-fitting electrodeof FIG. 16 on a left ear viewed from above a front of the ear;

FIG. 24 is a fragmentary, partially transparent, perspective view of theform-fitting electrode of FIG. 16 on a left ear viewed from above therear of the ear;

FIG. 25 is a fragmentary, partially transparent, perspective view of theform-fitting electrode of FIG. 16 on a left ear viewed from above thefront of the ear;

FIG. 26 is a perspective view of an exemplary embodiment of aform-fitting electrode application device;

FIG. 27 is a fragmentary, horizontally cross-sectional view of anexemplary embodiment of a form-fitting and force-fitting electrodeapplication device in a natural open configuration and displayed wherean auricle would be located;

FIG. 28 is a fragmentary, horizontally cross-sectional view of theform-fitting and force-fitting electrode application device of FIG. 27in a partially expanded configuration after installed on an auricle;

FIG. 29 is a fragmentary, horizontally cross-sectional view of anexemplary embodiment of a form-fitting electrode application device witha liner;

FIG. 30 is a fragmentary, horizontally cross-sectional view of analternative embodiment of the form-fitting and force-fitting electrodeapplication device of FIG. 29 in a natural open configuration anddisplayed where an auricle would be located;

FIG. 31 is a fragmentary, horizontally cross-sectional view f theform-fitting and force-fitting electrode application device of FIG. 30in a partially expanded configuration after installed on an auricle;

FIG. 32 is a fragmentary, horizontally cross-sectional view of anexemplary embodiment of a form-fitting electrode application device witha liner and a hinged frame in an open configuration;

FIG. 33 is a fragmentary, horizontally cross-sectional view of theform-fitting electrode application device of FIG. 32 with the hingedframe in a partially closed configuration;

FIG. 34 is a fragmentary, horizontally cross-sectional view of theform-fitting electrode application device of FIG. 32 with the hingedframe in a partially closed configuration and with a magnetic closure;

FIG. 35 is a fragmentary, horizontally cross-sectional view of theform-fitting electrode application device of FIG. 34 with the hingedframe in a closed configuration;

FIG. 36 is a fragmentary, horizontally cross-sectional view of theform-fitting electrode application device of FIG. 16 with an exemplaryembodiment of an extending electrode assembly;

FIG. 37 is a fragmentary, perspective view of the form-fitting electrodeapplication device of FIG. 36 with an exemplary embodiment of anelectrode conduit and generator;

FIG. 38 is a fragmentary, horizontally cross-sectional view of theform-fitting electrode application device of FIG. 16 with anotherexemplary embodiment of an extending electrode assembly in an idealizednon-flexed position;

FIG. 39 is a fragmentary, horizontally cross-sectional view of theform-fitting electrode application device of FIG. 38 with the extendingelectrode assembly in a flexed position;

FIG. 40 is a fragmentary, horizontally cross-sectional view of theform-fitting electrode application device of FIG. 16 with anotherexemplary embodiment of an extending electrode assembly in a held-openposition;

FIG. 41 is a fragmentary, horizontally cross-sectional view of theform-fitting electrode application device of FIG. 16 with anotherexemplary embodiment of an extending electrode assembly in a naturalclosed position;

FIG. 42 is a perspective view of an exemplary embodiment of aform-fitting electrode application device with boom connection areas;

FIG. 43 is a fragmentary, perspective view of the form-fitting electrodeapplication device of FIG. 16 with an exemplary embodiment of an earbudassembly;

FIG. 44 is a perspective view of a form-fitting and force-fittingelectrode application device in an open configuration;

FIG. 45 is a perspective view of the form-fitting and force-fittingelectrode application device of FIG. 44 in a partially openconfiguration;

FIG. 46 is a perspective view of the form-fitting and force-fittingelectrode application device of FIG. 44 in a partially openconfiguration;

FIG. 47 is a side elevational view of the form-fitting and force-fittingelectrode application device of FIG. 44 in a closed configuration;

FIG. 48 is a fragmentary, perspective view of the form-fitting andforce-fitting electrode application device of FIG. 44 closed on an earand viewed from above the front of the ear;

FIG. 49 is a fragmentary, partially transparent, perspective view of theform-fitting and force-fitting electrode application device of FIG. 44on an ear and in a partially closed configuration;

FIG. 50 is a fragmentary, side perspective view of an exemplaryembodiment of an neurostimulator device with electrode booms extendingto a trigeminal/temporal location;

FIG. 51 is a fragmentary, perspective and laterally cross-sectional viewof the neurostimulator device of FIG. 50;

FIG. 52 is a fragmentary, side perspective view of an exemplaryembodiment of a tragus neurostimulator device;

FIG. 53 is a fragmentary, rear perspective view of the tragusneurostimulator device of FIG. 52;

FIG. 54 is a fragmentary, perspective and laterally cross-sectional viewof the neurostimulator device of FIG. 52;

FIG. 55 is a fragmentary, perspective, partially transparent, andlaterally cross-sectional view of the neurostimulator device of FIG. 52;

FIG. 56 is a fragmentary, side perspective view of an exemplaryembodiment of the tragus neurostimulator device of FIG. 53 with anelectrode boom;

FIG. 57 is a fragmentary, perspective, partially transparent, andlaterally cross-sectional view of the neurostimulator device of FIG. 56;

FIG. 58 is a fragmentary, side perspective view of an exemplaryembodiment of an ear lobe neurostimulator device;

FIG. 59 is a fragmentary, front perspective and verticallycross-sectional view of the ear lobe neurostimulator device of FIG. 58;

FIG. 60 is a fragmentary, side perspective view of an exemplaryembodiment of a superior helix neurostimulator device;

FIG. 61 is a fragmentary, rear perspective and verticallycross-sectional view of the superior helix neurostimulator device ofFIG. 60;

FIG. 62 is a fragmentary, perspective view of an exemplary embodiment ofan electrode headset device;

FIG. 63 is a fragmentary, perspective view of the electrode headsetdevice of FIG. 62;

FIG. 64 is a fragmentary, perspective view of the electrode headsetdevice of FIG. 62;

FIG. 65 is a fragmentary, perspective and laterally cross-sectional viewof an upper portion of the electrode headset device of FIG. 62 viewedfrom below;

FIG. 66 is a fragmentary, partially transparent, perspective view of anexemplary embodiment of an over-the-ear electrode headset device viewedfrom a side of the ear,

FIG. 67 is a fragmentary, side perspective and sagitally cross-sectionalview of an exemplary embodiment of a dual-purpose,earbud/neurostimulator device with leads and speaker removed;

FIG. 68 is a fragmentary, side perspective and coronally cross-sectionalview of the earbud/neurostimulator device of FIG. 67;

FIG. 69 is a fragmentary, side perspective view of an exemplaryembodiment of a dual-purpose, earbud/neurostimulator device with leadsand speaker removed for clarity;

FIG. 70 is a fragmentary, side perspective and sagitally cross-sectionalview of the earbud/neurostimulator device of FIG. 69;

FIG. 71 is a fragmentary, side perspective view of an exemplaryembodiment of a dual-purpose, earbud/neurostimulator device with leadsand speaker removed for clarity;

FIG. 72 is a fragmentary, side perspective and sagitally cross-sectionalview of the earbud/neurostimulator device of FIG. 71;

FIG. 73 is a fragmentary, side perspective and sagitally cross-sectionalview of an exemplary embodiment of an adjustable magnetic attachmentforce neurostimulator device;

FIG. 74 is a diagrammatic illustration of a exemplary embodiment ofplacement of an electrode configuration;

FIG. 75 is a diagrammatic illustration of a exemplary embodiment ofplacement of another electrode configuration;

FIG. 76 is a diagrammatic illustration of a exemplary embodiment ofplacement of another electrode configuration;

FIG. 77 is a front elevational view of an exemplary embodiment of aneurostimulator device within a packaging/charging station;

FIG. 78 is a front perspective view of the neurostimulator device andpackaging/charging station of FIG. 77 viewed from the right sidethereof;

FIG. 79 is a rear elevational view of the neurostimulator device andpackaging/charging station of FIG. 77;

FIG. 80 is a front perspective view of the neurostimulator device andpackaging/charging station of FIG. 77 viewed from the left side thereof;

FIG. 81 is an enlarged, exploded, partially cross-sectional andpartially hidden perspective view of an exemplary embodiment of adual-purpose earbud/neurostimulator device;

FIG. 82 is an enlarged, partially cross-sectional and partially hiddenperspective view of the earbud/neurostimulator device of FIG. 81 in anassembled state;

FIG. 83 is an enlarged, side perspective view of theearbud/neurostimulator device of FIG. 81 in the assembled state;

FIG. 84 is an enlarged, side perspective view of an exemplary embodimentof the ear piece of the earbud/neurostimulator device of FIG. 81;

FIG. 85 is an enlarged, side perspective view of an exemplary embodimentof the ear piece of the earbud/neurostimulator device of FIG. 81;

FIG. 86 is an enlarged, side perspective view of an exemplary embodimentof the ear piece of the earbud/neurostimulator device of FIG. 81;

FIG. 87 is an enlarged, side perspective view of an exemplary embodimentof the ear piece of the earbud/neurostimulator device of FIG. 81;

FIG. 88 is an enlarged, side perspective view of an exemplary embodimentof the ear piece of the earbud/neurostimulator device of FIG. 81;

FIG. 89 is an enlarged, side perspective view of an exemplary embodimentof the ear piece of the earbud/neurostimulator device of FIG. 81;

FIG. 90 is an enlarged, side perspective view of an exemplary embodimentof the ear piece of the earbud/neurostimulator device of FIG. 81;

FIG. 91 is an enlarged, exploded, partially hidden, side perspectiveview of another exemplary embodiment of a dual-purposeearbud/neurostimulator device;

FIG. 92 is an enlarged, top plan view of the body of the device of FIG.91 with a first exemplary embodiment of a connection configuration;

FIG. 93 is an enlarged, top plan view of the body of the device of FIG.91 with a second exemplary embodiment of a connection configuration;

FIG. 94 is an enlarged, cross-sectional view of an exemplary embodimentof the ear piece of the earbud/neurostimulator device of FIG. 81;

FIG. 95 is a top plan view of an exemplary embodiment of a headbandearbud/neurostimulator device;

FIG. 96 is a fragmentary, enlarged top plan view of a distal end of thedevice of FIG. 95 with an earbud/neurostimulator device;

FIG. 97 is a diagrammatic perspective view of the device of FIG. 95 wornabout a user's head;

FIG. 98 is a top plan view of an exemplary embodiment of anotherheadband earbud/neurostimulator device;

FIG. 99 is a top plan view of an exemplary embodiment of a furtherheadband for an earbud/neurostimulator device;

FIG. 100 is a fragmentary, exploded, perspective view of an exemplaryembodiment of an earbud-type neurostimulator device with amulti-electrode flower-shaped electrode coupler;

FIG. 101 is a fragmentary, enlarged, exploded, perspective view ofportions of the earbud-type neurostimulator device of FIG. 100 includinga strain relief, a speaker assembly, a speaker housing stud, and anearbud core assembly;

FIG. 102 is a fragmentary, enlarged, perspective view of the earbud-typeneurostimulator device of FIG. 100 with the earbud core assemblyinstalled on the speaker housing stud;

FIG. 103 is an enlarged, perspective view of the earbud core assembly ofthe earbud-type neurostimulator device of FIG. 100;

FIG. 104 is a fragmentary, exploded, perspective view of an exemplaryembodiment of an earbud-type neurostimulator device with amulti-electrode flower-shaped electrode coupler;

FIG. 105 is a fragmentary, enlarged, exploded, perspective view ofportions of the earbud-type neurostimulator device of FIG. 104 includinga strain relief, a speaker assembly, a speaker housing stud, and anearbud core assembly;

FIG. 106 is a fragmentary, enlarged, perspective view of the earbud-typeneurostimulator device of FIG. 104 with the earbud core assemblyinstalled on the speaker housing stud;

FIG. 107 is an enlarged, perspective view of the earbud core assembly ofthe earbud-type neurostimulator device of FIG. 104;

FIG. 108 is a top plan view of an exemplary embodiment of an electrodecoupling subassembly for the multi-electrode coupler of FIG. 100;

FIG. 109 is a side elevational view of the electrode couplingsubassembly of FIG. 124 with a differently shaped conductor;

FIG. 110 is a top plan view of the electrode coupling subassembly ofFIG. 124 rotated ninety degrees;

FIG. 111 is a side elevational view of the electrode couplingsubassembly of FIG. 126 with the conductor of the subassembly of FIG.109;

FIG. 112 is a partially cross-sectional, partially perspective view ofan exemplary embodiment of an electrode coupling subassembly for themulti-electrode coupler of FIG. 100;

FIG. 113 is a fragmentary, exploded, perspective view of an exemplaryembodiment of an earbud-type neurostimulator device with amulti-electrode flower-shaped electrode coupler;

FIG. 114 is a fragmentary, enlarged, exploded, perspective view ofportions of the earbud-type neurostimulator device of FIG. 113 includinga strain relief, a speaker assembly, a speaker housing stud, and anearbud core assembly;

FIG. 115 is an enlarged, perspective view of the earbud core assembly ofthe earbud-type neurostimulator device of FIG. 113;

FIG. 116 is a fragmentary, exploded, perspective view of an exemplaryembodiment of an earbud-type neurostimulator device with amulti-electrode flower-shaped electrode coupler;

FIG. 117 is a fragmentary, enlarged, perspective view of a speakerhousing stud of the earbud-type neurostimulator device of FIG. 116;

FIG. 118 is an enlarged, perspective view of an earbud core assembly ofthe earbud-type neurostimulator device of FIG. 116;

FIG. 119 is a fragmentary, exploded, perspective view of an exemplaryembodiment of an earbud-type neurostimulator device with amulti-electrode flower-shaped electrode coupler;

FIG. 120 is a fragmentary, enlarged, perspective view of a speakerhousing stud of the earbud-type neurostimulator device of FIG. 119;

FIG. 121 is an enlarged, perspective view of the speaker housing stud ofthe earbud-type neurostimulator device of FIG. 119;

FIG. 122 is a fragmentary, perspective view of the earbud-typeneurostimulator device of FIG. 116 in an assembled state;

FIG. 123 is a fragmentary, perspective view of the earbud-typeneurostimulator device of FIG. 119 in an assembled state;

FIG. 124 is a fragmentary, exploded, perspective view of an exemplaryembodiment of an earbud-type neurostimulator device with amulti-electrode flower-shaped electrode coupler;

FIG. 125 is a fragmentary, enlarged, perspective view of portions of theearbud-type neurostimulator device of FIG. 124 in an assembled statewithout an earbud;

FIG. 126 is an enlarged, perspective view of the speaker housing stud ofthe earbud-type neurostimulator device of FIG. 124;

FIG. 127 is an enlarged, top plan view of the earbud-typeneurostimulator device of FIG. 125;

FIG. 128 is a fragmentary, enlarged, side elevational view of theearbud-type neurostimulator device of FIG. 125;

FIG. 129 is a perspective view of conductive leads of the earbud-typeneurostimulator device of FIG. 124;

FIG. 130 is a diagrammatic side elevational view of an exemplaryembodiment of an earbud-type neurostimulator device with an earbudremoved;

FIG. 131 is a diagrammatic side elevational view of the earbud-typeneurostimulator device of FIG. 130 rotated ninety degrees;

FIG. 132 is a cross-sectional view of a an exemplary embodiment of anearbud-type neurostimulator device;

FIG. 133 is a side elevational view of the neurostimulator device ofFIG. 132 rotated ninety degrees with the earbud removed;

FIG. 134 is a top plan view of the neurostimulator device of FIG. 132;

FIG. 135 is a top plan view of the neurostimulator device of FIG. 134rotated ninety degrees;

FIG. 136 is a block circuit diagram of an exemplary embodiment of asignal and transmission architecture for providing neuromodulation witha combined generator and controller and a remote device coupler;

FIG. 137 is a block circuit diagram of an exemplary embodiment of asignal and transmission architecture for providing neuromodulation witha combined generator, controller and device coupler;

FIG. 138 is a block circuit diagram of an exemplary embodiment of asignal and transmission architecture for providing neuromodulation witha controller and a remote generator and device coupler;

FIG. 139 is a block circuit diagram of an exemplary embodiment of asignal and transmission architecture for providing neuromodulation witha combined generator and controller, a remote device coupler, and anaudio source;

FIG. 140 is a front perspective view of an exemplary embodiment of anelectrostimulation signal generation and transmission device;

FIG. 141 is a top perspective view of the device of FIG. 140;

FIG. 142 is a front perspective view of another exemplary embodiment ofan electrostimulation signal generation and transmission device;

FIG. 143 is a front perspective view of a further exemplary embodimentof an electrostimulation signal generation and transmission device;

FIG. 144 is a graph of an exemplary embodiment of an electrostimulationprocess using an output of a constant polarity square wave with breaks;

FIG. 145 is a graph of an exemplary embodiment of an electrostimulationprocess using an output of an alternating polarity square wave with aconstant pulse and breaks;

FIG. 146 is a graph of an exemplary embodiment of an electrostimulationprocess using an output of an alternating polarity modulated sine wave;

FIG. 147 is a graph of an exemplary embodiment of an electrostimulationprocess using an output of an alternating polarity modulated sine wavewith breaks;

FIG. 148 is a graph of an exemplary embodiment of an electrostimulationprocess using a continuous square wave pulse having a sine wavemodulated amplitude with a modulated frequency dependent upon amplitude;

FIG. 149 is a graph of an exemplary embodiment of an electrostimulationprocess using a continuous square wave pulse having a sine wavemodulated amplitude at a constant frequency with no polarity group;

FIG. 150 is a graph of an exemplary embodiment of an electrostimulationprocess using an audio band amplitude modulated pulse output;

FIG. 151 is a graph of an exemplary embodiment of an electrostimulationprocess using an audio band amplitude modulated pulse output withbreaks;

FIG. 152 is a diagrammatic illustration of an exemplary embodiment of adisplay;

FIG. 153 is a diagrammatic illustration of an exemplary embodiment of adisplay;

FIG. 154 is a circuit diagram of an exemplary embodiment of a powercontrol and voltage regulation circuit for an electrostimulation device;

FIG. 155 is a circuit diagram of an exemplary embodiment of a pulsegeneration circuit for an electrostimulation device;

FIG. 156 is a circuit diagram of an exemplary embodiment of an audioinput circuit, a sensitivity adjustment circuit and a display circuitfor an electrostimulation device;

FIG. 157 is a rear perspective view of an exemplary embodiment of atrigeminal and temporal stimulator headband;

FIG. 158 is a perspective view from above a side of the trigeminal andtemporal stimulator headband of FIG. 157;

FIG. 159 is a top plan view of the trigeminal and temporal stimulatorheadband of FIG. 157 with pivoting contact booms;

FIG. 160 is a top plan view of the headband of FIG. 157 in place on auser's head;

FIG. 161 is a side elevational view of an exemplary embodiment of anelectrostimulation electrode earbud;

FIG. 162 is a perspective view from an audio out end of theelectrostimulation electrode earbud of FIG. 161;

FIG. 163 is a plan view from a housing end of the electrostimulationelectrode earbud of FIG. 161;

FIG. 164 is a perspective view from the housing end of theelectrostimulation electrode earbud of FIG. 161;

FIG. 165 is a side elevational view of an exemplary embodiment of anelectrostimulation electrode earbud;

FIG. 166 is a perspective view from an audio out end of theelectrostimulation electrode earbud of FIG. 165;

FIG. 167 is a plan view from a housing end of the electrostimulationelectrode earbud of FIG. 165; and

FIG. 168 is a perspective view from the housing end of theelectrostimulation electrode earbud of FIG. 165.

DETAILED DESCRIPTION OF THE INVENTION

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention, which can be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present invention in virtually anyappropriately detailed structure. Further, the terms and phrases usedherein are not intended to be limiting; but rather, to provide anunderstandable description of the invention. While the specificationconcludes with claims defining the features of the invention that areregarded as novel, it is believed that the invention will be betterunderstood from a consideration of the following description inconjunction with the drawing figures, in which like reference numeralsare carried forward.

Alternate embodiments may be devised without departing from the spiritor the scope of the invention. Additionally, well-known elements ofexemplary embodiments of the invention will not be described in detailor will be omitted so as not to obscure the relevant details of theinvention.

Before the present invention is disclosed and described, it is to beunderstood that the terminology used herein is for describing particularembodiments only and is not intended to be limiting. The terms “a” or“an”, as used herein, are defined as one or more than one. The term“plurality.” as used herein, is defined as two or more than two. Theterm “another,” as used herein, is defined as at least a second or more.The terms “including” and/or “having,” as used herein, are defined ascomprising (i.e., open language). The term “coupled.” as used herein, isdefined as connected, although not necessarily directly, and notnecessarily mechanically.

Relational terms such as first and second, top and bottom, and the likemay be used solely to distinguish one entity or action from anotherentity or action without necessarily requiring or implying any actualsuch relationship or order between such entities or actions. The terms“comprises,” “comprising,” or any other variation thereof are intendedto cover a non-exclusive inclusion, such that a process, method,article, or apparatus that comprises a list of elements does not includeonly those elements but may include other elements not expressly listedor inherent to such process, method, article, or apparatus. An elementproceeded by “comprises . . . , a” does not, without more constraints,preclude the existence of additional identical elements in the process,method, article, or apparatus that comprises the element.

As used herein, the term “about” or “approximately” applies to allnumeric values, whether or not explicitly indicated. These termsgenerally refer to a range of numbers that one of skill in the art wouldconsider equivalent to the recited values (i.e., having the samefunction or result). In many instances these terms may include numbersthat are rounded to the nearest significant figure.

It will be appreciated that embodiments of the invention describedherein may be comprised of one or more conventional processors andunique stored program instructions that control the one or moreprocessors to implement, in conjunction with certain non-processorcircuits and other elements, some, most, or all of the functions of thedevices and methods described herein. The non-processor circuits mayinclude, but are not limited to, signal drivers, clock circuits, powersource circuits, and user input and output elements. Alternatively, someor all functions could be implemented by a state machine that has nostored program instructions, or in one or more application specificintegrated circuits (ASICs) or field-programmable gate arrays (FPGA), inwhich each function or some combinations of certain of the functions areimplemented as custom logic. Of course, a combination of theseapproaches could also be used. Thus, methods and means for thesefunctions have been described herein.

The terms “program.” “software,” “software application.” and the like asused herein, are defined as a sequence of instructions designed forexecution on a computer system or programmable device. A “program,”“software,” “application,” “computer program,” or “software application”may include a subroutine, a function, a procedure, an object method, anobject implementation, an executable application, an applet, a servlet,a source code, an object code, any computer language logic, a sharedlibrary/dynamic load library and/or other sequence of instructionsdesigned for execution on a computer system.

Herein various embodiments of the present invention are described. Inmany of the different embodiments, features are similar. Therefore, toavoid redundancy, repetitive description of these similar features maynot be made in some circumstances. It shall be understood, however, thatdescription of a first-appearing feature applies to the later describedsimilar feature and each respective description, therefore, is to beincorporated therein without such repetition.

Described now are exemplary embodiments. Referring now to the figures ofthe drawings in detail and first, particularly to FIG. 1, there is showna first exemplary embodiment of an electrostimulator with a user couplercontaining a pair of electrodes (indicated diagrammatically and circledwith a dashed line). An electromagnetic pulse generator 1 includes theuser surge button 2, which allows a user to direct the generator 1 (witha button depression) to impart a predetermined output signal of apre-set duration of an increased or different signal modulation, i.e.,if the user has a back pain flair after lifting, he/she is able todepress the user surge button 2 to have an “as needed” higher dose ofstimulation. The generator 1 also includes a control 3 (e.g., a dial)that can turn on and off the generator 1 and/or alter settings in thedevice to provide variable and various settings. The generator 1 alsocan include a data screen or monitor 4 to provide visual indication orfeedback to a user.

A conduit 5 for transmitting signals to the user coupling devices 8 isconnected to the generator 1. Splitter conduits 6 supply dedicatedsignals to one or more pairs of the user couplers 8 (a second pair 8being indicated with dashed lines). Each of the user couplers in thisembodiment has a magnetic component 7 (i.e., a reciprocal magneticelement). In other words, each of the pair of couplers 8 has one of thereciprocal magnetic elements 7 that attract each other, thus creatingand maintaining proper contact (and maintaining proper impedance)between the contact leads of the user couplers and the body surface.With two pairs of user couplers 8, signal can be applied to twodifferent body surface sites. Other exemplary embodiments can includegreater than these two pairs of user couplers 8 (or two sets of usercouplers 8 and a common ground).

FIG. 2 depicts the device of FIG. 1 with a single pair of user couplersapplied to a user target area about the user's ear 9. The contact lead 5transmits a signal(s) from the splitter conduit 6 to the user's bodysurface, here, about the ear 9. The user couplers are pressed and heldagainst the skin of the ear 9 by the magnetic component 7 and, thereby,allow transmission of an electromagnetic signal through the user's bodysurface, thus affect the targeted structure.

In an exemplary embodiment, the user couplers can have a common groundlocally or remotely (i.e., to the portion of the generator that would bein contact with the skin). Ground may have a heating device that causesincreased blood flow or perspiration, thereby decreasing impedance andincreasing signal transfer to the target structure.

In the exemplary embodiment shown, the generator 1 can be a stand-alonedevice. As an alternative, for example, the generator 1 can be asmartphone that has software for carrying out the signal transmission asan app on the smartphone, indicated diagrammatically with the dashedlines 10 in FIG. 2.

In the exemplary embodiment of FIG. 2, neuromodulation of the vagusnerve can occur for treating various conditions, such as for painrelief. Characteristics of the vagus nerve are that it is a cranialnerve having both efferent (motor) and afferent (sensory) transmission.The vagus nerve has been identified as a conduit towards treatingconditions such as the sensations of pain, emotions (e.g., well-being,pleasure, depression), the ability to concentrate, the occurrence ofseizures, and disorders of the limbic system.

Such therapy utilizing the external (non-invasive) systems and methodsdescribed herein for the vagus nerve references a diagram of the humanear in FIG. 3. It is known that the vagus nerve has a branch that passesclose to the concha of the ear. The concha forms a concave bowl shapeand comprises the cymba above the crus of the helix and the cavum belowthe crus of the helix. The inventors have discovered that areas of theear are particularly useful for applying neuromodulation to the vagusnerve: the concha and the posterior auricle (the back side of the earopposite the concha) and a portion of the ear canal. The first two ofthese therapy regions are identified in FIGS. 4 and 5 with the conchalregion 50 and the auricle region 60 highlighted.

A first exemplary embodiment of a system such as those described withregard to FIGS. 1 and 2 is illustrated in FIGS. 4 and 5. Therein, aconduit 5 for transmitting signals to the coupling devices is connectedto the generator 1. One portion of the conduit 5′ provides a positiveside of the signal to electrodes 8 and another portion 6 of the conduit5 supplies a negative or ground side of the signal to the electrodes 8.In the exemplary embodiment shown, there are three electrodes 8 on thepositive side. There can be a corresponding set of three electrodes 8 onthe negative side behind the ear (not illustrated) or there can be asingle grounding electrode 8 behind the ear as shown in FIG. 4. Each ofthe electrodes 8 can have a magnetic component 7 (i.e., a reciprocalmagnetic element) to secure to the surface of the ear. If there is aferrous material 7 on the back side of the ear, a grounding electrode 8′could be present on the same side of the ear as the positive electrodes8. Such a configuration is illustrated with a dashed line leading to theelectrode 8′ in FIG. 4. Each of the positive electrodes 8 can besupplied with the same or different signals. In the latter case, thegenerator 1 can apply a variable signal pattern that utilizes feedbackfrom the user. When the signal is providing the user with a beneficialresult, the generator 1 can be caused to retain the signal patterncurrently being applied for the therapy period. When the signal is notproviding the user with a beneficial result, the generator 1 can becaused to change the signal pattern currently being applied to adifferent signal pattern or, if there are multiple electrodes 8, tochange how the electrodes apply the signal. For example, if a signalfrom one of the three electrodes 8 and electrode 8′ are beneficial, thenthe electrode 8′ can be paired with another of the three electrodes 8.Alternatively, the negative or ground and positive can be switched aboutto have a signal occur between two of the three electrodes 8.Alternatively or additionally, three different signals can be applied toeach of the three electrodes 8. In this manner, if one or two or evenall three of the signals being applied to a portion of the concha(through respective device couplers 8) achieve a beneficial result, thediffering topographies and impedances of the ear can be rendered moot.

In an alternative exemplary embodiment, the grounding electrode 8′ canbe a position maintaining device (indicated in FIG. 4 with a largedashed line) connected to the conduit 5′ (e.g., with a shielded piece ofNitinol). This Nitinol can have its own dedicated current supply, that,when applied, heats the wire and, therefore, bends the Nitinol towardsthe inner surface of the ear to move its contact point towards the skin,not only to enhance position maintenance, but also to decreaseimpedance.

The electrodes 8, 8′ can take various forms. As describe above withregard to FIGS. 1 and 2, the user couplers can simply be a pair ofelectrodes. FIGS. 16 to 28, in comparison, show two differentconfigurations.

In FIGS. 8 and 9, an array of three electrodes 810 are provided in theconchal region 50 and a single grounding electrode 820 is provided inthe auricle region 60. Any of the herein-described signals can beprovided to each of the electrodes 810, 820 to provide therapeuticbenefit to the vagus nerve. An exemplary embodiment of the generator 900is shown in FIG. 9. The generator 900 includes a display 910, controlbuttons 920, and a surge button 930.

In FIG. 8, an array of five electrodes 810 are provided in the conchalregion 50 and a single grounding electrode (not illustrated) is providedin the auricle region 60. Any of the herein-described signals can beprovided to each of the electrodes 810 to provide therapeutic benefit tothe vagus nerve. An exemplary embodiment of the generator 900 is shownin FIG. 9. The generator 900 includes a display 910, control buttons920, and a surge button 930.

In embodiments where a surge button is included, the generator can givea user control of “emergency” electrostimulation dosing. This isbeneficial in instances where the individual is experiencing an aura(i.e., a harbinger to a seizure) and the user may not have the generatoractivated. By providing the surge button, even where the generator isturned off, the generator can be programmed to allow the user totransmit a high power signal expeditiously and avert a seizure using thesurge button. Another use of the surge button occurs when the user isusing the generator actively for therapy but results are not occurring.In such a case, the user may desire a dose of electrostimulation athigher power. The surge button affords the user the ability to receivethat dose the moment the button is pressed, serving to override thecurrent therapy and deliver a pre-programmed, higher dose ofelectrostimulation for a predetermined time. Other processes that can becarried out with the buttons of the generator include a continuoushigh-power signal to be delivered for the duration that the button isdepressed. The actuation element could be in any form, whether a button,a switch, a voice command, a touch screen input, or a voice input. In anemergency situation, a “high dose” feature can also be activated basedupon the generator sensing some physiologic data, through a variety ofsensors that can be attached to the generator as needed (e.g., bloodpressure, temperature, respiration) and the generator can respond byactivating the override if the sensors reach a pre-programmed parameteror condition. In comparison, if the device is using one of the on-boardalgorithms, such as a “ramp up” algorithm that is described below,activating the generator in a standard manner will not give an immediate“high power signal”.

FIGS. 10 to 15, in comparison, show a transcutaneous vagus nervestimulation system having a VNS generator 1000 with a dockable electrodeapplication device 1010. In this exemplary embodiment, the electrodeapplication device 1010 can be wireless to have the electrodes 1012communicate with the VNS generator 1000, for example, by Bluetooth® orWi-Fi. Alternatively, connectivity between the VNS generator 1000 andthe two electrodes 1012 of the electrode application device 1010 iswired, for example, like the embodiment of FIG. 1. The VNS generator1000 includes a display 1120, control buttons 1122, and a surge button1124. The VNS generator 1000 has a docking station 1060 that, in thisexemplary embodiment, comprises a post 1062 extending from a dockingblock 1064. When the electrode application device 1010 is undocked, anon-illustrated bias device (such as a spring), biases the electrodes1012 towards one another. In such a configuration, when placed on anear, for example as shown in FIGS. 12, 14, and 15, the bias devicecompresses the two electrodes 1012 against opposing tissue of theconchal 50 and auricle 60 regions to attach the electrodes 1012 in placefor therapeutic use. In this configuration where the electrodes 1012 aresimply “button-like.” the interior opposing surfaces of the electrodes1012 have thereon a skin-fastening device (such as an adhesive) so that,when placed on the ear, the button electrodes 1012 stick to the exteriorsurfaces. When allowed to spring shut on the ear, the bias device forcesthe two electrodes 1012 towards one another to, thereby, fasten(temporarily) the electrodes 1012 on the ear until they are to beremoved. Because the force that the skin-fastening device has on the earis greater than the force keeping the electrodes 1012 on the electrodeapplication device 1010, the electrodes 1012 separate from the electrodeapplication device 1010 when the latter is moved away from the ear asshown in FIG. 15. One benefit to this embodiment is that it eliminatesthat pain that is caused by constant compression of a clipped device.

To dock the electrode application device 1010 at the VNS generator 1000,the user moves the proximal arms 1016 of the electrode applicationdevice 1010 towards one another to align the arms 1016 sufficiently toform a central port 1014 having an interior shaped correspondingly tothe exterior shape of the post 1062, thereby allowing the electrodeapplication device 1010 to be slid down the post 1062 and self-lock theelectrode application device 1010 to the VNS generator 1000 with thedistal arms 1018 separated for new electrode replacement.

The configuration of the electrode application device 1010 as a scissorallows either or both of the two sides to have more than one electrode.For example, one side can have two electrodes and the other can have oneelectrode or a grounding electrode. Alternatively, both sides can havethree electrode pairs aligned with one another. Any configuration ofelectrodes to place at least one of the electrodes in one of the conchal50 or auricle 60 regions is envisioned to supplement the embodimentsdescribed herein.

The configuration of the electrode application device 1010 is notlimited to a scissor-type clamping action. The two sides of theelectrode application device 1010 can be clamshell-shaped and springloaded. In such a configuration, the opposing members have a one-handoperation for ease of placement by a user. Alternatively, the hinge canbe configured like the bi-modal hinge of clip-on earrings.

The scissor configuration of the electrode application device 1010 is aforce-locking device, as opposed to a form-locking device. The electrodeapplication clip or Helix Cuff 1610 shown in FIGS. 16 to 18, 20 to 29,and 36 to 43, in comparison, is a form-fitting device. The Helix Cuff1610 has a posterior portion 1620, an anterior portion 1630, and abridge portion 1640 connecting the posterior and anterior portions 1620,1630. Each of the posterior and anterior portions 1620, 1630 has arespective electrode or set of electrodes. In this exemplary embodiment,the posterior portion 1620 has a single grounding electrode 1622 and theanterior portion 1630 has a pair of positive electrodes 1632. Signalscan be provided to the Helix Cuff 1610 either wirelessly, through awire, or both (a wire being illustrated in FIG. 37).

Each of the posterior and anterior portions 1620, 1630 has a respectiveshape to fit the anatomy of an ear. Before describing the Helix Cuff1610 in detail, it is beneficial to discuss the anatomy of a human earwith regard to FIGS. 3 and 17. Even though each person has his/her ownparticular shape and size for each ear (and the two ears of one personare different from one another), there is one common feature that ispresent on the helix of virtually every ear. In particular, the helixcurves upwards and forward in an ovular shape towards the crus of helix.As the helix spirals downwards and then centrally inwards towards theconcha, the end portion of the crus of helix defines an axis 1700 thatdivides an upper portion 1710 of the rear helix from a lower portion1720 of the rear helix. Where the axis 1700 bisects the rear helix is ahelix portion that is substantially straight. This straight helixportion is defined herein as the central helix 1730. It is the centralhelix 1730 that is present in virtually all shapes of a human ear. Withthis central helix 1730 discovered, the inventors shaped the Helix Cuff1610 to fit the central helix 1730, the shape being a form-fit thatretains, very comfortably, the Helix Cuff 1610 on the central helix 1730of a human ear. FIG. 18 illustrates the Helix Cuff 1610 placed on thecentral helix 1730 and FIG. 19 illustrates a transverse cross-section ofthe Helix Cuff 1610 at the axis 1700.

The particular shape of the Helix Cuff 1610 facilitates attachment to anear by following the perimeter of natural anatomical geometries. In thisway, fixation occurs in each of the ±X, ±Y, and ±Z axes. The Helix Cuff1610 is generally U-shaped and surrounds the anterior and posteriorhelix and antihelix. The valley 1642 of the U-shape rests up against thehelix. The anterior portion 1630 has a first anterior curve 1830 thatenters the concha and has a second anterior curve 1832 that curves inthe opposite direction of the first anterior curve 1830. The length ofthe anterior portion 1620 of the U-shape can be as long as the anteriorside of the helix, the antihelix, or the concha and, in an exemplaryembodiment, extends approximately 15 to 25 mm, in particular,approximately 17 mm, from the valley 1642 of the Helix Cuff 1610. Theposterior portion 1620 of the U-shape has a first posterior curve 1820in the posterior direction to wrap around the helix and has a secondposterior curve 1822 that curves in the opposite direction of the firstposterior curve 1820. The length of the posterior portion 1620 of theU-shape can be as long as the posterior side of the ear to touch thehead 1840 behind the ear or can be a distance therefrom, as is shown inFIG. 18. In an exemplary embodiment, the length of the posterior portion1620 extends approximately 10 to 20 mm, in particular, approximately 13mm from the valley 1642 of the Helix Cuff 1610.

The Helix Cuff 1610 has a vertical height (see FIG. 17) sufficient tohave it remain within the substantially straight central helix 1730 andis, in this exemplary embodiment, substantially symmetric about the axis1700. As will be described below, the Helix Cuff 1610 can be but neednot be substantially symmetric about the axis 1700.

With the shape as described, movement of the Helix Cuff 1610 isrestricted in every direction once installed at the central helix 1730of the ear. In particular and with regard to FIG. 18, movement isrestricted in the direction of the +X axis by the first anterior curve1830. Tension of the Helix Cuff 1610 in the +X direction is borne byinterior curved surface of the anterior portion 1630 of the Helix Cuff1610 and the anterior concha surface and/or antihelix. Movement isrestricted in the direction of the −X axis by the interior surface ofmost of the “U” shape of the Helix Cuff 1610 and, primarily, by thevalley 1642. Tension of the Helix Cuff 1610 in the −X direction is borneby the interior surface of the “U” shape, e.g., the valley 1642, and theouter surface of the helix. Movement is restricted in the direction ofthe +Y axis by the interior surface of the posterior portion 1620.Tension of the Helix Cuff 1610 in the +Y direction is borne by theinterior surface of the posterior portion 1620 and the posterior surfaceof the ear opposite the helix and antihelix. Movement is restricted inthe direction of the −Y axis by the interior surface of the anteriorportion 1630. Tension of the Helix Cuff 1610 in the −Y direction isborne by the interior surface of the anterior portion 1630 and theanterior surface of the helix, the antihelix, and/or the concha.

Movement with regard to the Z axis is described with reference to FIG.17. In particular, movement is restricted in the direction of the +Zaxis by the superior surfaces and edges of the Helix Cuff 1610. Tensionof the Helix Cuff 1610 in the +Z direction is borne by the superiorsurfaces and edges on the Helix Cuff 1610 and the natural curvature ofthe helix and the antihelix in the −X direction and elevation of thecrus of helix and the concha in the +Y direction. Movement is restrictedin the direction of the −Z axis by the inferior surfaces and edges ofthe Helix Cuff 1610. Tension of the Helix Cuff 1610 in the −Z directionis borne by the inferior surfaces and edges of the Helix Cuff 1610 andthe natural curvature of the helix and the antihelix in the −X directionand elevation of the crus of helix and the concha in the +Y direction.Similarly, any rotation of the Helix Cuff 1610 about the three axes isrestrained by the same principals.

With such a shape, the Helix Cuff 1610 provides many beneficialfeatures. First, for example, the Helix Cuff 1610 indexes to theattachment location, facilitating ease of self-application. Theattachment location of the central helix is exposed completely to theuser. Significantly, the attachment location at the central helix is anatural convergence point (e.g., axis 1700) for many anatomicalfeatures, such as the curves of the superior and inferior portions ofthe helix, the antihelix, and the concha. The user is able to easilyidentify the location by visually or tactilely following the crus ofhelix and the helix to helix's central straight section.

Second, the Helix Cuff 1610 is surprisingly comfortable and, after ashort time, the user no longer feels its presence. This is because themeasures for attaching the Helix Cuff 1610 to the ear use geometricconstraints without applying constant pressure on the auricular surface.As is known, constant pressure on auricular surfaces is uncomfortable,such as the pressure exerted by clip-on earrings. In addition, theattachment zone of the Helix Cuff 1610 resides on an especially inactivenerve. For such a small part of the anatomy, four different sensorynerves connect to the external ear. As shown in the diagram of FIG. 19,these nerves are (1) the greater auricular nerve, (2) the lesseroccipital nerve, (3) the auricular branch of the vagus nerve, and (4)the auriculotemporal nerve. The greater auricular nerve is a branch ofthe cervical plexus. It innervates the posteromedial, posterolateral,and inferior auricle (lower two-thirds both anteriorly and posteriorly).The lesser occipital nerve innervates a small portion of the helix. Theauricular branch of the vagus nerve innervates the concha and most ofthe area around the auditory meatus. Finally, the auriculotemporal nerveoriginates from the mandibular branch of the trigeminal nerve. Itinnervates the anterosuperior and anteromedial aspects of the auricle.It is known that in the perimeter portion of the ear (sections 2 and 4)are less influential than the portion of the ear lobe (section 1) andthat the lesser occipital nerve communicates with a zone that is lessinfluential than the other three.

Third, the central helix is centrally situated for therapeutic targetlocations. As shown in FIGS. 17, 20, and 21, the Helix Cuff's 1610central attachment location provides an optimum platform for therapeuticfeatures such as electrodes and electrode booms (illustrateddiagrammatically in FIG. 21 with lines projecting from the Helix Cuff1610) that target strategic stimulation points (indicated by triangles).The attachment location about the crus of helix line (e.g., axis 1700)allows any boom(s) targeting auricular stimulation points to be shortand not rely on additional support features other than the Helix Cuff1610 itself, as will be described in further detail below. As the fieldof neuromodulation is evolving, a robust, universal platform that caneasily target a particular location in the ear, such as that describedherein, is desirable.

Fourth, as shown in FIGS. 22 and 23, the Helix Cuff 1610 does notocclude the auditory canal 2200. This means that the Helix Cuff 1610does not inhibit placement of a traditional audio ear bud or otherauditory canal device and, as is described in further detail below,actually provides a platform for synergistic use of the neuromodulationdevices and methods with traditional, personal, auditory transmissiondevices.

Finally, the Helix Cuff 1610 can be, in the exemplary embodimentillustrated, ambidextrous. One Helix Cuff 1610 can be placed on bothears with equal comfort and ease, independent of the particulargeometries of the two cars. If a single coupler system is desired, anambidextrous Helix Cuff 1610 is required. In the exemplary embodimentsillustrated, the Helix Cuff 1610 is geometrically symmetric about eachof the planes that are affected by right and left ear applications.While symmetric embodiments are illustrated herein, it is equallyenvisioned to customize one or more Helix Cuffs 1610 in a way that istailored to a specific location site or to deliver neuromodulation at aparticular location.

As mentioned, the electrodes need not be located solely on the outersurfaces of the Helix Cuff 1610. Electrode contact point(s) orsurface(s) of the Helix Cuff 1610 can be located on any surface thatcontacts an auricular surface. The electrodes can be onlyground/negative, only positive, or both. The shape of the electrodes canbe varied, including, for example, spherical, hemispherical, pyramidal,columnar, and contoured to anatomical curvature. With regard to theexemplary configuration show in FIGS. 8, 24, and 25, there can be twopositive anterior electrodes 1632 each having a pyramidal shape and oneposterior ground electrode 1622 having a plate-like shape. Materials usefor the electrode(s) include, for example, metals (e.g., biocompatible,hypoallergenic, precious), conductive polymers, conductive composites,conductive foams, and conductive coatings applied to a soft surface.Each of the electrodes can be shaped to receive a conductive pad, forexample, a gel pad that is single or multiuse and can be user applied.Exterior contact surfaces of the electrodes can be textured, such aswith serrations or barbs, to increase conductivity. In an exemplaryembodiment where percutaneous connectivity is desired, the electrodescan be/have needles that pierce the surface of the skin. The surface ofthe electrodes can also be optimized for applied gel retention.

Another exemplary configuration of electrodes is shown in FIG. 26, inwhich an array of surface electrode plates 2600 are disposed about theinterior surfaces of the Helix Cuff 1610. Here, the electrode plates2600 are disposed in a single line from the distal end of the interioranterior surface to the distal end of the interior posterior surface. Asdesired, the electrode plates 2600 can be disposed on the exteriorsurfaces and the distal ends. Further, the electrode plates 2600 areillustrated as a series of plates along one single line. Each of theseplates can be divided into upper and lower (or left and right) halves inparallel (not illustrated) or they can be asymmetrically disposed platesabout any of the exterior surfaces of the Helix Cuff 1610.

The Helix Cuff can also include some force-fitting features. Forexample, as shown in FIGS. 27 and 28, the Helix Cuff 2700 is, in itsneutral state (FIG. 27), at a U-shape that is narrower than the auricle2710. When attached, as shown in FIG. 28, the Helix Cuff 2700 flexesoutwards and conforms to the geometry of the auricle 2712. Compressionapplied by the strength of the cuff is maintained in a comfortablepressure range. An adjustable clamp limiter can be implemented to limitcontinuing spring force from the spring clamp frame by a user adjustableor preset physical stop to govern the clamp gap dimension or a useradjustable or preset force limiting feature to govern clamping force. Toenhance compression, if desired, magnets can be attached to thereciprocal inner surfaces of the U-shape.

Shapes and fit can be altered by use of material. In an exemplaryembodiment, the Helix Cuff 1610, 2700 is composed of a low durometermaterial (e.g., between 10 and 70 on the Shore OO scale and, inparticular, between 20 and 40). Such materials can include,thermopolymer/thermoset rubbers, foams and viscoelastic materials forexample, silicone, polyeurathane, and neoprene. Regardless of where theelectrodes are placed on or at the Helix Cuff 1610, 2700, 2900, ifdesired, the interior surface can be coated with a soft liner 2910, suchas that shown in FIG. 29, and, additionally or alternatively, can becombined with a Helix Cuff 2700 that is, in its neutral state, narrowerthan the auricle 2710 (FIG. 30) but expands when installed (FIG. 31) tomaintain a comfortable range of pressure on the auricle. This relativelysofter liner 2910 (relatively being defined with respect to itsdifference from the frame of the Helix Cuff 2700) can also have variousdimensions indicative of different auricular size ranges (e.g., small,medium, large). If desired, a user can be provided with a liner insert2910 that best fits the user's ear. The sizing liner 2910 can also berigid.

The Helix Cuffs 1610, 2700, 2900 mentioned above are of a single part.In another exemplary embodiment, the Helix Cuff 3200 can have a two-part(e.g., clamshell) configuration 3210, 3220 that is connected together bya hinge 3230. In alternative embodiments, the Helix Cuff 3200 can becomposed of a rigid frame 3210, 3220 with the central hinge 3230, aninner liner 3240, and reciprocal magnets 3250 to clamp the frame parts3210, 3220 onto the auricle. The hinged frame 3210, 3220, 3230 can alsocontain a non-illustrated adjustable stop to limit the magnetic clampingforce. Alternatively, the hinged frame 3210, 3220, 3230 can be a“floppy” unhinged component that uses the magnets 3250 to clamp onto theauricle.

An alternative to the hinge is a multi-modal spring clamp analogous to aclip-on earring. In such a configuration, the multimodal spring clamp isin a locked open position. When placed into an intermediate springclosing position, a spring closure takes over and presses the two halvesinto a closed position. Such a configuration aids in indexing andattachment onto an auricle. The multi-modal spring claim can be closedto a stop to limit compression or to continuously apply compression onthe auricle.

As mentioned herein, for example with regard to FIG. 21, electrodes canextend away from the main body of the Helix Cuff 1610, 2700, 2900, 3200to contact various vagus nerve stimulation locations within the ear, inparticular, within the concha and ear canal. Such electrodes can beintegral with or removably added to the main body of the Helix Cuff1610, 2700, 2900, 3200. Electrode booms can be disposed directionally inall planes to satisfy connection direction between the Helix Cuff and atarget location for neuromodulation. Electrode booms generally containthree main features: a structural member or beam, an electrical conduit,and an end effector (e.g., an electrode and/or a sensor). These featurescan be combined into a single part and that part can be integral with orremovably connected to the Helix Cuff.

FIGS. 36 to 39, for example, illustrate one exemplary embodiment of aHelix Cuff 3600 with an electrode boom assembly 3610 comprised of anelectrode 3612, an electrode connector 3614, and an electrical conduit3616 conductively connecting the electrode 3612 to the generator(through an electronic conduit 3718) or to a contact at the Helix Cuff3600 that is, in turn, connected to the generator 3720, which is shownonly diagrammatically. The electrode boom assembly 3610 is used totarget specific stimulation locations and/or to sense a particularposition on the anterior or posterior surface of the auricle.

The electrode connectors 3614 shown in FIGS. 36 and 37 are rigid beamshaving a particular shape. In an alternative embodiment, the electrodeconnectors can be a flex spring 3814 having a natural position thatinterferes with the auricle when the Helix Cuff 3600 is installed. Sucha configuration flexes to comply with auricular geometry. The electrodeconnector 3814 can be of shape memory and super elastic, for example. Inanother alternative embodiment, the electrode connectors 4014 can beconnected to the Helix Cuff 3600 by a spring pivot hinge comprising apivot 4000 and a spring 4002. The spring 4002 provides a force to pressthe contact point of the electrode 4012 to the surface of the auricle.The electrode connector 4014 can be locked in open position, cancontinuously provide a force, and/or can have an adjustment device tolimit the applied force. The beam of the electrical connector 4014 canbe rigid or it can flex. In the latter case, the flexing beam canprovide the force-limiting feature. The hinge point of the pivot hingecan be a lockable universal joint. The electrical connector 4014 neednot be a beam. It can be a flexing wire lead with an electrode(s) at itsend(s). Likewise, the electrode conduit can be a wire or conductivesupport member. Further, the electrode connector 4014 can be surfaceconforming, of a soft foam rubber extension of the Helix Cuff thatcontours to targeted auricular surface.

In an exemplary embodiment that can be applied to all instances where anelectrode boom is desired, any version of the Helix Cuff 1610, 2700,2900, 3200, 3600 can be provided with insertable boom members 4200,4210, 4220, examples of which are diagrammatically shown in FIG. 42.These are not the only shapes for the boom, and variations are equallypossible. Explanation of the first exemplary boom member 4200 is madeand is equally applicable to every configuration of a boom member. Theboom member 4200 comprises a distal electrode 4202, a boom 4204, and acontact stub 4206. The entire boom member 4200 can be electricallyconductive or a non-illustrated internal conductor can connect theconductive distal electrode 4202 to the proximal end surface of thecontact stub 4206, at which is a conductor 4208 for receiving thesignal. The boom members 4200, 4210, 4220 connect conductively to theHelix Cuff 1610, 2700, 2900, 3200, 3600 through blind holes 4240 thatare disposed anywhere on the outside surfaces of the Helix Cuff 1610,2700, 2900, 3200, 3600. Exemplary locations for the blind holes 4240 areillustrated in FIG. 42, although many other locations are possible. Whatis relevant is that the blind holes 4240 be disposed at the surface ofthe Helix Cuff 1610, 2700, 2900, 3200, 3600 (e.g., orthogonally or at anangle thereto) to place the distal electrode 4202 at a treatmentlocation on the tissue to be treated (e.g., at the locations shown inFIGS. 33, 34, 50). Thus, for example, the blind holes 4240 can bedisposed on any of the surfaces of the posterior portion 1620, anteriorportion 1630, bridge portion 1640, or on the inferior, superior, and/oredge surfaces, as shown in FIG. 42. These blind holes 4240 can have anelectrically conductive interior surface that makes electric contactwith any portion of the outer surface of the contact stub 4206 or theycan have a distal conductor disposed at the bottom surface of the blindhole 4240 (e.g., a protrusion in the shape of a pyramid or hemisphere).

Because the Helix Cuff 1610, 2700, 2900, 3200, 3600 does not interferewith the auditory canal, any standard set of earbuds can be used at thesame time. The earbuds can be entirely separate from the Helix Cuff1610, 2700, 2900, 3200, 3600 or they can, as shown in FIG. 43, removablyattached to the Helix Cuff 1610, 2700, 2900, 3200, 3600. In particular,an earbud retention device 4300 is part of or removably attached to theHelix Cuff 1610, 2700, 2900, 3200, 3600. Earbud restraint is a knowndisadvantageous issue with simple earbud designs. By attaching theearbuds 4310 to the Helix Cuff 1610, 2700, 2900, 3200, 3600 (e.g.,removably), earbud restraint issues are eliminated.

The embodiment of the electrode application clip 1610 of FIGS. 16 to 18,20 to 26, 29, and 36 to 43 is connected to the ear only by aform-fitting connection. In contrast, the electrode application clip4410 of FIGS. 44 to 49 is connected to the ear by both a form-fittingand force-fitting connection. More specifically, the interior shape ofthe both the outer and inner portions 4420, 4430 have approximately thesame interior shape of the outer and inner portions 1620, 1630. Theouter portion 4420 is, in this exemplary embodiment, one piece and hasan inner electrode 4422 (e.g., ground/negative). The inner portion 4430in this embodiment, however, is not one piece and is not fixed. Twoouter arms 4434 each have a respective positive electrode 4432 and eachare independently connected pivotally to the bridge 4440. The pivotingconnection can be provided by an interior axle about which the armspivot or can be provided by protrusions/depressions that are present butnot illustrated between the proximal ends of each arm 4434 and theinterior surfaces of two slots 4442 present at the bridge 4440, one foreach of the arms 4434. Openable closeability of the arms 4434 can beprovided merely from friction of the opposing elements themselves (whichcan be dependent upon the material(s) of the arms 4434 and the slots4442 of the bridge 4440) or it can be provided by separate devicespresent within the arms 4434 or within the bridge 4440. Such closingdevices can include springs or pivots, for example, that bias the arms4434 in the closed position, shown in FIG. 47. As each of the arms 4434can close down upon the ear independently, customized placement and wellas customized comfort can be achieved. For example, as shown in FIG. 49,only one of the arms 4434 can be closed and used during therapeutictreatment if desired. FIG. 49 illustrates the process of clipping theelectrode application clip 4410 to an ear. First, the outer portion 4430is placed against the rear/posterior surface of the ear and then the twoarms 4434 are moved to place the inner surfaces of the arms 4434 againstthe concha of the ear.

Electrodes are not limited to placement or extension within the conchaof the ear. Electrodes can be placed at other portions at or around theear as well. As shown in FIGS. 50 and 51, the Helix Cuff 1610, 2700,2900, 3200, 3600 is provided with two electrode booms 5010 (comprisingan electrode 5012, an electrode connector 5014, and a non-illustratedelectrical conduit). The booms 5010 extend across the tragus to touch atemporal location near or at the area of the trigeminal nerve.

As set forth above, the central helix is one beneficial location forproviding an electrode stimulation clip, such as the Helix Cuff. Otherareas of the ear are also beneficial locations for providing anelectrode stimulation clip. One exemplary alternative embodiment isshown in FIGS. 52 to 55, in which the electrode stimulation clip is aTragus Cuff 5200. All of the features of the Helix Cuffs describedherein are equally applicable to the Tragus Cuff 5200. This means, forexample, that the Tragus Cuff 5200 can be a form fit to a shape of aperson's tragus or can be a form and force fitting shape for the tragus.Electrodes can be placed on the Tragus Cuff 5200. In the exemplaryconfiguration illustrated in FIGS. 52 to 55, electrodes on the interiorsides of either the anterior 5210 or posterior 5220 portions of theTragus Cuff 5200 can be used to deliver electrostimulation to thetemporal region and/or to the trigeminal nerve. Shown in FIG. 55, forexample, is a plate-type electrode 5510 on the posterior side of thetragus near the auditory canal. Similarly, electrodes extend from theTragus Cuff 5200 on booms 5610 or other extension features, such asthose illustrated in FIGS. 56 and 57, for example.

Another exemplary alternative embodiment is shown in FIGS. 58 and 59, inwhich the electrode stimulation clip is a Lobe Cuff 5800. All of thefeatures of the Helix Cuffs described herein are equally applicable tothe Lobe Cuff 5800. This means, for example, that the Lobe Cuff 5800 canbe a form fit to a shape of a person's ear lobe or can be a form andforce fitting shape for the ear lobe. Electrodes (not illustrated) canbe placed on the Lobe Cuff 5800. In the exemplary configurationillustrated in FIGS. 58 and 59, electrodes on the interior sides ofeither the anterior 5810 or posterior 5820 portions of the Lobe Cuff5800 can be used to deliver electrostimulation to the ear lobe, to thetemporal region, to the trigeminal nerve, and/or to the concha.Similarly, electrodes can extend from the Lobe Cuff 5800 on booms orother extension features, for example.

Still a further exemplary alternative embodiment is shown in FIGS. 60and 61, in which the electrode stimulation clip is a Superior Helix Cuff6000. All of the features of the Helix Cuffs described herein areequally applicable to the Superior Helix Cuff 6000. This means, forexample, that the Superior Helix Cuff 6000 can be a form fit to a shapeof a person's superior helix or can be a form and force fitting shapefor the superior helix. Electrodes (not illustrated) can be placed onthe Superior Helix Cuff 6000. In the exemplary configuration illustratedin FIGS. 60 and 61, electrodes on the interior sides of either theanterior 6010 or posterior 6020 portions of the Superior Helix Cuff 6000can be used to deliver electrostimulation to the helix and/or to theconcha. Similarly, electrodes can extend from the Superior Helix Cuff6000 on booms or other extension features, for example.

Further exemplary embodiments include headphone-like or earbud devicesthat have integrated electrodes, with or without an independent powersource, that, when the headphones/earbuds are connected to the audiosource, such as a smartphone, that audio source has a softwareapplication serving as the user interface and signal generator. But,these devices need not be solely purposed as neurostimulators. Theearbuds/headphone can also be dual-purpose devices where the earbuds andconnected smartphone act as both an audio device and as aneurostimulator device. Various exemplary embodiments of such devicesare depicted in FIGS. 43, 62 to 66, 67 to 72, 81 to 135, 142, 143, and161 to 168.

First. FIGS. 62 to 65 show a dual-purpose headphone andelectrostimulation device 6200 with an attached generator and controller6210 and user coupler integrated into the ear contact ring 6220. The earcontact ring 6220 is traditionally foam or soft material and covers mostof the auricle and can house single electrode arrays or electrode pairarrays. Electrodes 6510 can protrude from or be shaped surfaces on theear contact ring 6220 with conductive-coated areas 6512 or rigidconductive components. Additionally, a compliant or rigid contouringelectrode carrier 6230 (for ground or a reciprocal polarity) is shown onthe posterior side of the auricle. The power source between headphoneand the electrostimulation generator can be shared.

An alternative exemplary embodiment shown in FIG. 66 is an over-the-earelectrode device 6600 that does not have integrated speakers (althoughaddition of speakers is an option). This electrode device 6600 has anear cuff 6602 that positions the positive electrode(s) 6614 disposed ata distal end 6610 within the concha (see the transparent distal end ofthe ear cuff 6602 in FIG. 66) and the negative or grounding electrode(s)6630 on a surface of a proximal end of the ear cuff 6602 behind the ear.The ear cuff 6602 can be of soft silicone defining an electrode supplyconduit, which conduit can be malleable to provide stiffness and/orshape forming features. The form fit of the curved ear cuff 6602provides sufficient force to keep the electrodes 6614, 6630 in contactwith the ear surfaces and sufficient resistance to prevent the ear cuff6602 from moving about the ear. For example, when the signal supplyconduit 6650 becomes tangled or is pulled or jerked, those forces areabsorbed by the ear and not by the distal portion of the ear cuff 6602that houses the electrode 6614. Nonetheless, additional securing devicescan be provided. For example, a magnetic device pair can be place withone part (not illustrated) on the distal end 6610 having the positiveelectrode(s) 6614 and the other part opposing the first part on theproximal end of the cuff 6602. For example, the negative electrode 6630can also be the second magnetic part. It is noted, thereby, that theembodiment of FIG. 66 illustrates the property of utilizing the curve ofthe ear to accept and hold all forces imparted by the environment on thesignal supply conduit 6650 that would tend to move the electrodes or theelectrode devices away from the intended stimulation targets, forexample, as depicted by arrow A in FIG. 69. This configuration for thesignal supply conduit is equally applicable for any of thenon-wirelessly supplied electrode device configurations describedherein, including but not limited to each of the Helix Cuffs 1610, 2700,2900, 3200, 3600, 4410, 5200, 5800, 6000 and to each of the earbuds8130, 9130, 9430, 9510, 10060, 11660, 12460, 13260, 14242, 16100, 16500.

FIGS. 67 to 70 illustrate various embodiments of dual-purposeearbud/neurostimulator devices. The first exemplary embodiment of adual-purpose earbud/neurostimulator device 6700 is shown in FIGS. 67 and68. Here, the central audio speaker is not shown for purposes ofclarity. The earbud base 6730 houses an external positive electrode 6710that surrounds at least a portion of the outside surface of the base6730 for secure adhesion and, in particular, places the positiveelectrode 6710 in direct contact with the conchal region 50 of the ear.Behind the ear, in the auricle region 60, is a negative or groundelectrode 6720. These two electrodes can be connected together by anon-illustrated clip or other device that wraps around the helix of theear or they can have corresponding magnetically coupling counterparts.Supply leads 6740, for both electrodes and the speaker of the earbud,are shown diagrammatically in FIG. 67 with dashed lines.

A second exemplary embodiment of a dual-purpose earbud/neurostimulatordevice 6900 is shown in FIGS. 69 and 70. Again, the central speaker isnot shown for purposes of clarity. The earbud base 6930 houses a set ofexternal positive electrodes 6910 that surrounds at least a portion ofthe outside surface of the base 6930 for secure adhesion and, inparticular, places at least one of the positive electrodes 6910 directcontact with at least one portion of the conchal region 50 of the ear.Behind the ear, in the auricle region 60, is a negative or groundelectrode 6920. The front and rear electrodes can be connected togetherby a non-illustrated clip or other device that wraps around the helix ofthe ear or they can have corresponding magnetically couplingcounterparts. Supply leads 6940, for both electrodes and the speaker ofthe earbud, are shown diagrammatically in FIG. 70 with dashed lines.

A further exemplary embodiment of a dual-purpose earbud/neurostimulatordevice 7100 is shown in FIGS. 71 and 72. The central speaker 7102 isshown in FIG. 71 but is removed for purposes of clarity in FIG. 72. Thisexemplary embodiment is similar to the embodiment shown in FIGS. 69 and70 except for the addition of an electrode extension 7132 extending tothe conchal region 50, which extension 7132 placed a/another positiveelectrode 7110 thereon with a bias force, for example, from the curvedshape of the extension 7132. Also provided is a correspondingnegative/ground electrode 7220 disposed at the auricle region 60 of theear.

FIG. 73 illustrates a user coupler 7300 including a first body 7330holding a magnetic component as well as an electrode 7310 that serves asthe electrically positive contact point at the conchal 50 region of theear. Additionally, there is a least one other magnetic electrode 7320serving as the ground or electrically negative point that tracks througha non-illustrated conduit and back to the generator to complete thecircuit. The electrode 7320 is placed at the auricle 60 region of theear. At least one of the electrodes contains a magnet and the other ofthe electrodes contains ferrous material or an oppositely charged magnetallowing the electrodes to be in reciprocal positions on or about theskin such that the target structure to be stimulated is within theelectromagnetic field generated by the signal generator. By turning thescrew 7332 attached to the magnet 7334, a distance between the magneticattraction point is decreased or increased, thereby adjusting clampingforce tight or loose against the ear.

As described above, application of neurostimulation to an auricle canoccur in various ways. Electrode arrays can be placed on anterior orposterior auricular surfaces, for example. The three configurations7400, 7500, 7600 for electrodes illustrated in FIGS. 74 to 76 are asubset of some basic configurations for electrode arrays. In particular,in the first exemplary configuration 7400 in FIG. 74, one or moreelectrodes are placed in the concha and a grounding electrode is placedat another portion of the user's body, for example, at the posteriorside of the auricle. In the second exemplary configuration 7500 in FIG.75, both positive and negative electrodes (or electrode arrays) areplaced in the concha. In the third exemplary configuration 7600 in FIG.76, one or more electrode pairs are placed in the concha and scapha.

FIGS. 77 to 80 show an exemplary embodiment of a user coupler in apackaged state. Even though this user coupler is similar to theembodiment illustrated in FIGS. 50 and 51, the configuration ofpackaging 7700 illustrated herein is applicable to all of the varioususer coupler embodiments described herein. The user coupler is fixed tothe packaging 7700 by an attachment device 7710, such as a scale modelof an ear or other target anatomy. Benefits of this attachment device7710 include a complete constraining of the user coupler to protect itfrom transportation damage with a simultaneous instruction to the userof a correct target location, as well as to show what a correctapplication of the user coupler should look like. The packaging 7700 canbe fully or partially clear to provide the consumer with an unobstructedview of the user coupler as well as the ear model 7710. One or more ofthe features of the systems and methods described herein, such asaudio-synchronized pulsing lights, can be activated (for example by apower module 8010 having an on/off switch 8011) while the user coupleris in the packaging 7700. Another exemplary feature of the packaging7700 is that the attachment device 7710 can also be a user couplerstorage dock and/or charging dock when not in use.

Other exemplary embodiments of a dual-purpose earbud/neurostimulatordevice move neuromodulation into the ear canal. Such devices takeadvantage of the fact that the vagus nerve and branches thereof areclose to and at the inner surfaces of the ear canal. By placingelectrodes inside the ear canal, more direct access to the vagus nervebecomes possible. Various configurations of such devices are first shownin FIGS. 81 to 92.

With these characteristics in mind, reference is first made to FIG. 81to 84. In FIG. 81, a dual-purpose earbud/neurostimulator device 8100 isshown in an exploded view and FIG. 82 shows the parts in their assembledform. At the center is an electrode and audio platform 8102. Theplatform 8102 has a body 8104 that is relatively stiff as in othertypical earbud devices. The body 8104 can be made of, for example,polycarbonate, polyethylene (LDPE), high density polyethylene (HDPE),polypropylene (PP), polystyrene (PS), polyvinyl chloride (PVC), andPolytetrafluoroethylene (PTFE). The body 8104 houses the electroniccomponents of the device 8100. In particular, an internal audio speaker8106 is aligned to project sound through an audio canal 8108 and out tothe user when the device 8100 is placed in the user's ear canal. Theaudio canal 8108 can be of any acoustically beneficial shape and isshown only diagrammatically in FIGS. 81 and 82 with dotted lines. Theaudio speaker 8106 has electrical connections 8110 that extend back tothe generator and/or audio device through a cable 8112, diagrammaticallyshown with dashed lines. Audio signals are transmitted through theelectrical connections 8110 from the generator and/or audio device asthese can be separate or integral components. The body 8104 alsocontains positive and negative/ground electrode supplies 8114, 8116 thatelectrically connect to the generator though stimulation supply lines8118. In the exemplary embodiment, the positive and negative/groundelectrode supplies 8114, 8116 have bias devices that allow movement ofthe physical electrical connection portion towards and away from acentral longitudinal axis of the body 8104. These bias devices are showndiagrammatically in FIGS. 81 and 82. By applying an outward bias, theouter electrical connection surfaces are assured to keep contact withtheir respective counterparts on the insert 8120, which is slipped ontothe sound canal stub 8105 of the body 8104.

Even though the insert 8120 can be integral with the relatively soft earpiece 8130 or integral with the body 8104, it is separate in thisexemplary embodiment. The insert 8120 is hollow and has an interiorcavity shaped to fit snugly on the sound canal stub 8105 of the body8104. The insert 8120 has circumferential positive and negativeconnection bands 8122, 8124 each having an interior surface that iselectrically conductive and, when the insert 8120 is installed on thestub 8105, respective electrical connectivity is established between theinterior surface of each band 8122, 8124 and the electrode supplies8114, 8116. If desired, the bands 8122, 8124 can be collinear with theinterior surface of the insert 8120 or they can be offset, eitherinwards or outwards, to form a positive removable connection between theelectrode supplies 8114, 8116 when connected together. The bands 8122,8124 have a respective electrically conductive exterior surface thatinsulated from one another. This electrically conductive exteriorsurface also can be offset, either inwards or outwards. The exterioroffset can be offset in the same direction as the interior surface or itcan be opposite the offset of the interior surface so that there areeither rings extending outwards from both surfaces of the insert 8120 orthere are grooves extending inwards from each inner and outer surface.The distal end of the insert 8120 has an audio port 8126 that permitspassage of audio sound. The insert 8120 is made of a material that caneasily create the circumferential electrically conductive bands 8122,8124 and keep them electrically isolated and insulated from one another.For example, the insert is of pvc, rubber. PEEK, or latex.

The outermost part of the device 8100 is the ear piece 8130, sometimesreferred to as an earbud. As with conventional ear pieces, the ear piece8130 is soft to be comfortable when inserted within the ear canal of auser. Thus, the ear piece 8130 is relatively softer than the body 8104.The ear piece 8130 defines an inner cavity 8132 into which the insert8120 is placed when in use. The inner cavity 8132 has a correspondingshape to the exterior of the insert 8120 and, in an exemplaryembodiment, is sufficiently tight to prevent the ear piece 8130 fromfalling off of the insert 8120 or the body 8104 when in use. In anexemplary embodiment, the softness of the ear piece 8130 is such thatthe inner cavity 8132 can stretch a little to be press-fit over theinsert 8120 when the insert 8120 is on the stub 8105 and that stretchacts as a bias to retain both the insert 8120 and the ear piece 8130 onthe body 8104. The ear piece 8130 is formed with a sound channel 8134that permits audio from the speaker 8106 to exit and pass through toenter the user's ear canal. The inner cavity 8132 contains positive andnegative/ground connection areas 8136, 8138 at the inner surface thereofto electrically contact the exterior surfaces of the bands 8122, 8124 onthe insert 8120 when the ear piece 8130 is installed thereon. Theconnection areas 8136, 8138 can be simple printed electrical pads orrings or can be more complex, such as pogo pins. In any embodiment, theconnection areas 8136, 8138 pass through the material of the ear piece8130 and exit to the exterior surface 8139. The ear piece 8130 is madeof a material that can have electrical connections on the inner surfaceof the inner cavity 8132, can pass from the inner cavity 8132 throughthe material and to the exterior surface 8139, and can extend over anarea on the exterior surface 8139 of the ear piece 8130. The connectionareas 8136, 8138 in FIG. 81 are shown as inwardly extending, even thoughthis is diagrammatic. As an alternative to inwardly extending areas, theareas can be collinear with the surface or they can extend inwardly asprotrusions away from the surface of the inner cavity 8132. If theprotrusions are soft as well as being the conductive connection areas8136, 8138, then the protrusions can act as bias measures to pressagainst the bands 8122, 8124 and, thereby, maintain electricalconnectivity.

Neuromodulation electrodes on the exterior surface 8139 of the ear piece8130 can take any form. One exemplary embodiment is shown in FIG. 83, inwhich there are two pairs of connection areas 8136, 8138, each having apositive and a negative/ground. Other exemplary embodiments are shown inFIGS. 84 to 90. In FIG. 84, there is one pair of connection areas 8136,8138, each in the form of strips. In FIG. 85, the connection areas 8136,8138 are many, are in the form of circular pads, and are spread out overthe entirety of the exterior surface of the ear piece 8130. In FIG. 86,the connection areas 8136, 8138 are in the form of longitudinal stripscircumferentially spread out over the entirety of the exterior surfaceof the ear piece 8130, with the number of the connection areas 8136,8138 being different. Here, the number of positive electrode areas 8136is greater than the number of negative/ground electrode areas but theycan be reversed. In FIG. 87, the connection areas 8136, 8138 are in theform of circumferential rings or bands alternating from the base to thetip on the exterior surface of the ear piece 8130, with the number ofthe connection areas 8136, 8138 being different. Here, the number ofpositive electrode areas 8136 is greater than the number ofnegative/ground electrode areas but they can be reversed. In FIG. 88,the connection areas 8136, 8138 are in the form of small longitudinalstrips circumferentially spaced around the exterior surface of the earpiece 8130. The number of the connection areas 8136, 8138 are shown asbeing different but they can be the same in number or can be any numberof each. In FIG. 89, there is one pair of connection areas 8136, 8138,each in the form of a triangle. Finally, in FIG. 90, there are pairs ofstrip-shaped connection areas 8136, 8138 around the circumference of theear piece 8130, each pair having one positive between twonegative/ground. It is noted that each of the exemplary embodiments ofthe neuromodulation electrodes shown on the exterior surface 8139 of theear piece 8130 shown and described herein is merely exemplary. Theelectrodes can be in any shape or number.

The ear piece 8130 and the body 8104 connect in a so-called pin-and-boreform fit. Another exemplary embodiment for connecting these two parts isshown in the diagrammatic representations of FIGS. 91 to 93. The body9104 is similar to the body 8104 except there is no stub 8105. Instead,the body 9104 has connection ports 9106 into which connectors 9132 ofthe ear piece 9130 are removably inserted. FIG. 92 shows a singledirection connection in which the connectors 9132 insert longitudinallydirectly into the connection ports 9106 to removably hold the ear piece9130 to the body 9104 (e.g., with a press-fit). FIG. 93, in contrast,shows a multi-direction connection in which the connectors 9132 firstinsert longitudinally into the connection ports 9306 and, then, the earpiece 9130 is twisted (here, counterclockwise) to permit the distal headof the connectors 9132 to be captured within tracks 9308 of theconnection ports 9306, similar to a bayonet mount. If the heads of theconnectors 9132 form the electrical connection between the electrodesupplies 8114, 8116 of the body 9104 for delivering the neuromodulationsignals, then this connection mechanism provides a very stable andpositive electrical connection while, at the same time, allows the userto rotate the ear piece 9130 with respect to the body 9104 to betteralign the external electrodes (not illustrated) with the person's uniquevagus nerve anatomy at the ear canal. It is noted that the removableconnection between the body 9104 and the ear piece 9130 can take anyform and, therefore, the connection therebetween is not limited to theexemplary embodiments shown and described. It is noted that many of theparts of the body 9104 and the ear piece 9130 that are similar to theembodiment of FIGS. 81 to 83 have not been described or shown forclarity, but the descriptions are equally applicable.

FIG. 94 illustrates another exemplary embodiment of the ear piece forthe earbud/neurostimulator device. This ear piece 9430 is one thatprotrudes further into the ear canal and provides an improvement in thesealing of the outer surface of the ear piece 9430 to the surface of theear canal due to the staggered umbrella shapes. With the increasedsealing of the ear canal to the outer surfaces of the ear piece 9430,this configuration of the ear piece 9430 can be used in moist or wetenvironments, such as when swimming or bathing.

FIGS. 62 to 65 illustrate an over-the-head configuration of aneurostimulator device 6200. In that embodiment, the ear contact ring6220 cups over most or all of the ear. The ear contact ring 6220 can bereplaced with ear pieces on either side. FIGS. 95 to 97 illustrates suchan embodiment of a neuromodulation device 9500 with a C-shaped headband9502 having distal ends. An earbud/neurostimulator device 9510 is placedat one or both of the distal ends of the headband 9502. When worn, eachof the earbud/neurostimulator devices 9510 fits into a respective earcanal of a user. Each of the earbud/neurostimulator devices 9510 in FIG.95 has electrode contacts 8136, 8138 for delivering neurostimulation toboth ear canals. While electrode contacts 8136, 8138 are shown on bothof the earbuds, only one of the earbuds can have the electrode contacts8136, 8138 in a desirable alternative exemplary embodiment.Neurostimulation signals are provided to the earbud/neurostimulatordevice(s) 9510 through a cable 8112. The neurostimulation device 9500can be worn about the back of a user's head as shown in FIG. 97 or itcan be rotated about the axis between the user's ears to place theheadband under the user's chin (not illustrated). Beneficial to thisembodiment of the neurostimulation device 9500 is that the headband canbe of a material with spring-back properties such that, when the C-shapeof the headband 9502 is opened to fit on the user's head, thespring-back of the C-shape provides an inwardly directed force on theearbud/neurostimulator device 9510 to press it into the ear canal andimprove contact of the electrode contacts 8136, 8138 with the innersurfaces of the ear canal.

While the material of the headband 9502 can flex or be of a spring-backnature, mechanical devices can also be employed to press the distalearbud/neurostimulator device against and into a user's ear canal. Oneexemplary headband neurostimulation device 9800 is shown in FIG. 98, inwhich a headband 9802 includes pivot points 9804 at which a flex bar9806 is mounted. The midpoint of the headband 9802 has a threadedthroughbore in which is threaded an adjustment screw 9808. As such, whenthe screw 9808 is tightened, it presses against the centerpoint of theflex bar 9806, moving the centerpoint of the headband 9802 away from theflex bar 9806 and, thereby, causing the two earbud/neurostimulatordevices 9510 to move towards one another. As headbands that wrap arounda user's head are large and not easily stored, the headband 9802 can beprovided with fold points 9810 that retain the shape of the headband9802 when moved outwards as shown but also allow the distal ends torotate and fold inwards for easy storage when removed from a user'shead. Other portions of the headband neurostimulation device 9800 aresimilar to the exemplary embodiments described herein and are,therefore, not repeated.

Similar functions can be accomplished by the embodiment of the headband9902 shown in FIG. 99. This headband 9902 has a main body 9904 havingtwo outwardly projecting arms 9906 and a center point at which islocated a spindle holder 9908. A hollow spindle 9920 is mounted in thespindle holder 9908 in a freely rotatable manner such that opposing cams9922 threaded into the hollow of each of the opposing sides of thespindle 9920 can move inwards and outwards together as the spindle 9920is spun in either direction. The distal ends of the cams 9922 are eachconnected to a first end 9932 of a pivot bar 9930, which pivot bar 9930is pivotally connected to a respective distal end of an arm 9906 at apivot point 9910. In such a configuration, as the cams 9922 are movedinwards, the first end 9932 moves towards the spindle 9920 and thesecond end 9934 moves away from a centerline 9901 of the headband 9902.When the spindle 9920 is spun in the opposite direction, the cams 9922move outwards and the second ends 9934 close and move towards thecenterline 9901.

The earbud embodiments shown in FIGS. 81 to 99 are just a few exemplaryconfigurations for providing electrostimulation to the ear canal. Theconfiguration of FIGS. 81 to 83 and 91 to 93 envision earbuds that canbe utilized as stand-alone earbuds without headbands or they can be usedwith headbands, such as those illustrated in FIGS. 95 to 99. The generalconcept of the stand-alone electrostimulation earbuds is to provide aspeaker in a housing that cooperates with an earbud having externalelectrical contacts to deliver electrostimulation to the surface of theear canal while providing acoustic signals (such as music, white noise,an audio book, auditory pre-set patterns, and the like) into the earcanal through an acoustic delivery channel or port. Exemplaryembodiments of stand-alone electrostimulation earbuds are shown startingwith FIG. 100.

FIG. 100 depicts a first exemplary embodiment of a stand-aloneelectrostimulation earbud 10000. Starting from the bundle of electricalleads, including two 8110 for the speaker and two 8118 for theelectrostimulation signal, a strain relief 10010 guides the leads into aspeaker housing 10020 and is fixed within an entry port 10022. Thespeaker housing 10020 is semi-rigid and can be made of plastic, forexample, ABS. The speaker housing 10020 can be 3D printed if desired andforms an encasement for a device that holds a speaker therein. Inparticular, an internal hollow of the speaker housing 10020 receives aspeaker housing stud 10030, in which is held a speaker assembly 10040.The exemplary embodiment of the speaker housing stud 10030 shown in FIG.100 is shaped to hold a rectangular cuboid speaker assembly 10040, suchas the Sonion 2356, which is about 11 mm to 12 mm in maximum width.Thus, the outer diameter of the speaker housing 10020 can be as littleas about 14 mm. The speaker leads 8110 pass through the interior of thespeaker housing 10020 and are electrically connected to the speakerassembly 10040. Connection of the electrostimulation leads 8118 will beexplained below. Finally, the rear of the speaker housing 10020 can beshaped to provide a space for a decal or sticker 10070 printed with atrademark thereon or the space can form the logo itself, for example, byraised bosses or lowered channels, which logo can be back lit by, forexample, an LED that pulses and/or changes colors with theelectrostimulation signal.

When installed at the speaker housing 10020, the speaker housing stud10030 has a flange 10032 that, together with the strain relief 10010 andthe speaker assembly 11040, substantially seal off the interior of thespeaker housing 10020 from the environment. At its rear side, thespeaker housing stud 10030 has a speaker encasement 10031, best shown inFIG. 101, that securely holds the speaker assembly 10040 at the speakerhousing stud 10030. At its front side, the speaker housing stud 10030has a core-assembly stud 10034. The core-assembly stud 10034 has variousfeatures. First, sound from the speaker assembly 10040 needs to becommunicated to the user. In the particular exemplary embodiment ofFIGS. 100 to 103, the interior hollow of the core-assembly stud 10034forms a sound channel that communicates sound from the speaker assembly10040 to the user's inner ear. A second feature holds an earbud coreassembly 10050 to the core-assembly stud 10034 when the earbud coreassembly 10050 is connected thereto. In the particular exemplaryembodiment of FIGS. 100 to 103, the core-assembly stud 10034 has a splitmushroom end 10036 that is able to compress inwards when the earbud coreassembly 10050 is being installed thereon and then spring outwards whenthe surface of interior bore 10052 of the earbud core assembly 10050enlarges. The enlarged diameter portion 10054 of the interior bore 10052of the earbud core assembly 10050 can be seen in the right side of FIG.101 and in FIG. 103 and the split mushroom end 10036 is shown seated inthat expanded area in FIG. 102. A third feature of the core-assemblystud 10034 clocks the earbud core assembly 10050 to a pre-setinstallation orientation. In the particular exemplary embodiment ofFIGS. 100 to 103, the core-assembly stud 10034 has at least one clockingridge 10038 and, preferably, two clocking ridges 10038 on opposing sidesof the core-assembly stud 10034. This clocking feature will be describedin further detail below.

The flange 10032 has two electrical contacts that provide an electricalconduit for electrostimulation arriving through the electrostimulationleads 8118. As will be explained in the embodiments herein, this conduitcan take various forms. One exemplary configuration for theelectrostimulation leads 8118 shown in FIGS. 100 to 103 is anelectrically conductive bore or via 10033 on the earbud (or front) sideof the flange 10032. Each lead 8118 is connected to the bore 10033 atthe rear side of the flange 10032 in any way, for example, by solderingor press-fitting. On the opposite side of the flange 10032, the bore10033 provides an orifice in which a conductor is slidably received.

The earbud core assembly 10050 is semi-rigid and can be made of plastic,for example, ABS. The earbud core assembly 10050 can be 3D printed ifdesired and forms the structural support for the earbud 10060. Theearbud core assembly 10050 also has various features. First, the centralbore 10052 receives the core-assembly stud 10034 therein. The expandedportion 10054 is located at distal end of the central bore 10052 suchthat, when the core-assembly stud 10034 is temporarily locked therein,the distal end of the core-assembly stud 10034 does not protrude fromthe distal end of the earbud core assembly 10050. Although, if desired,the distal end can protrude therefrom. It is noted that the earbud 10060is most likely a disposable part and, therefore, is envisioned to bereplaced (although it can be reusable). Thus, it must be able to beremoved from either or both of the speaker housing stud 10030 and theearbud core assembly 10050. If desired, the earbud core assembly 10050can also be disposed along with the earbud 10060 or it can be retainedfor use with a replacement earbud 10060.

The earbud core assembly 10050 also has a set of electrostimulationconductors 10056 that, in this exemplary embodiment, are on opposingsides but they can be disposed at any two (or more) locations about theexterior surface of the earbud core assembly 10050. The conductors 10056each project entirely through a flange 10058 of the earbud core assembly10050 to form two rearward projecting extensions that can be insertedinto respective ones of the bores 10033 when the earbud core assembly10050 is correctly rotated (i.e., clocked) in an installation position.To provide this clocking, the interior surface of the central bore 10052has a non-illustrated groove that extends from the rear side of theflange 10058 starting from an open funnel shape necking down to a shapethat exactly matches the exterior shape of the clocking ridges 10038.The length that the clocking ridges 10038 extend away from the flange10032 of the speaker housing stud 10030 is set so that the rearwardprojecting extensions of the conductors 10056 are prevented from cominginto contact with the flange 10032 unless and until the two clockingridges 10038 are within the corresponding grooves of the central bore10052. In this way, the conductors 10056 automatically and assuredlyenter the bores 10033 and make electrical contact with the leads 8118.The conductors 10056 are shown as round wires but they can be of anypolygonal shape, including hexagonal, triangular, and square, forexample. As shown in FIG. 103, the conductors 10056 use their shape toremain fixed on the body of the earbud core assembly 10050. From theearbud side of the earbud core assembly 10050, the conductors 10056pinch the distal end of the stud 10057 of the earbud core assembly 10050with a 180-degree bend. Then, the conductors 10056 travel along thelength of the stud 10057 in a groove that keeps the conductors 10056resting therein but still projecting out from the outer surface of thestud 10057. The conductors 10056 then bend approximately 90 degreesoutwards and then 90 degrees rearward to project through the flange10058 and extend out the rear side thereof. In order to make contactwith conductive surfaces 10062, 10064 of the earbud 10060, it isimportant, in this exemplary embodiment, for the conductors 10056 toprotrude from the outer surface of the stud 10057. Any part or all ofthe portion of the conductors 10056 that extend along the exterior ofthe stud 10057 can be bent outwards to produce a bias that insuresconductive connection to conductive interior surfaces 10062, 10064 ofthe earbud 10060.

The earbud 10060 is the part that provides electrostimulation from thegenerator to the ear canal. In an exemplary embodiment, a body 10066 ofthe earbud 10060 is made of silicone and, therefore, it is flexible andsoft enough to place in a user's ear canal without discomfort. Theearbud 10060 is envisioned to be disposable (although it can bereusable). The earbud 10060 has eight leaves or tines. The number oftines is not significant as long as a first portion of the outer surfaceof the earbud 10060 can conduct one part (positive/negative/ground) ofthe electrostimulation and another different second portion of the outersurface of the earbud 10060 insulated from the first portion can conductthe other part (negative/ground/positive) of the electrostimulation. Inthe embodiment where eight tines are present, an adjacent set of threeof the tines conduct the first part of the signal and an adjacent set ofthree different tines conduct the other part of the signal, the twoindividual remaining tines separating and insulating the two sets ofthree. The earbud 10060 has an interior lumen 10068 that is sized to fitsnugly but removably on the stud 10057 of the earbud core assembly10050. Because the component inserted into an ear achieves the best fitif it is made of a conformal or malleable material, the electrode/sdisposed on the tissue contact surface of the earbud 10060 is/aremalleable as well across various surface area shapes and curvatures.Another characteristic of the electrode/s is that they are durable, donot functionally impair the earbud's ability to conform properly to theuser's anatomy, and are pragmatic/efficient to manufacture. With thesecharacteristics in mind, there are a number of different types ofmaterials and processes that can be used.

In various exemplary embodiments of the electrodes, to minimizerestriction of the malleability of the earbud, current supplied theretois advantageously conducted through a conduit within the inner lumen,out the lumen at the apex of the earbud, and continuing onto the outersurface of the earbud where tissue contact is to occur. One exemplaryprocess for manufacturing this conductive path is to mask off all areasthat are to remain non-conductive and then to spray or dip the maskedearbud into the conductive liquid. After curing or drying, the maskingis removed, leaving only the conduit portion of the electrode/s in theinner lumen contiguous with the electrode/s on outside surface of theearbud. Masking, as used herein, can be defined as coating the earbud onareas where the conductive liquid will not adhere and then renderingthese areas non-conductive after the insert is sprayed, dipped, or silkscreened, for example.

Another exemplary embodiment to provide conductivity to theelectrode-tissue interface is by coating a portion of the interior lumen10068 adjacent the first conductor 10056 and then extending that coatingaround the end of the lumen (to the right in FIG. 100) and onto theouter surface or tissue contact area of the patient coupler to form theone or more conductive surface 10062. These conductive tissue contactareas may have various configurations, geometries, surface areas, orbranching. Similarly, a portion of the interior lumen 10068 adjacent thesecond conductor 10056 may be coated and this coating is extended aroundthe end of the lumen and onto another location of the tissue contactarea of the coupler that is not in contact with the other coating(s) toform the second conductive surface 10064.

One way to apply the conductive coating is with an adhesive tapemanufactured by 3M, the tape having a conductive surface on one side anda silicone adhesive on the other, although other methods and devices areequally applicable as well. As used herein, the conductive coating maybe conductive inks, liquids, gels, glues, powders, foils, tapes, curableliquids, metallic materials, or other conductive malleable materials(conforming non-conductive materials that have conductive elements“blended” in them during their original manufacturing process renderingthem conductive). Thus, the word “coating” is to be broadly interpretedand not limited to only a single embodiment. Other ways to apply theconductive coating include, for example, spray coating, silkscreening/screen printing, dip coating, and manual painting, with anunderstanding that the coating geometry is highly specific. Thus,depending on the configuration on which the coating is to be applied,consideration is given to the level of precision present during theapplication process. In addition to a viscous coating, thin conductingstrips (such as aluminum foils) can be adhered to the earbud to createconducting paths that function as electrodes.

In this exemplary embodiment, there are two distinct areas of conductivecoatings: one serving as positive and the other serving as ground, eachof the coating trifurcating and covering an exterior portion of threetines for each current path. The location of the trifurcated portions ofthe conductive surfaces on the outer surface of the tines is positionedto be the location of the tissue contact areas. If two or more separateand electrically distinct coatings are used, they will be electricallyinsulated from each other by a separation or other insulating device.

The earbud itself can be manufactured by using at least two “halves” ofa conductive malleable material (e.g., conductive silicone) with atleast one insulation component that is made of the same material butwithout conductive properties. One exemplary form of this configurationis a sandwich with the two halves of the conductive material separatedby a laminate of the insulating material, the insulating materialapproximating the flexibility or other key properties of the conductive(electrode) halves.

In one exemplary molding process for manufacturing the earbuds, castaluminum or resin molds are created to the specifications of the earbud.Liquid material is injected into the mold and is allowed to set, afterwhich the conductive elements are added externally in any of the hereinmentioned ways, for example, by painting on a coating, by taping anegative image off and dipping the molded bud into conductive coating,or by physically applying conductive adhesive foil to the bud.

FIG. 104 depicts a second exemplary embodiment of a stand-aloneelectrostimulation earbud 10400. The strain relief, speaker housing,speaker housing stud, speaker assembly, and ear bud are all similar tothe embodiment of FIG. 100 and, therefore, will not be described infurther detail as the descriptions herein are applicable to the instantembodiment. What is different is the earbud core assembly 10450. In theparticular exemplary embodiment of FIGS. 104 to 107, the portion of theearbud core assembly 10450 that is different is how theelectrostimulation conductors 10456 travel and are attached to the stud10457 of the earbud core assembly 10450. With this one exception, allother attributes of the earbud core assembly 10450 are similar to theearbud core assembly 10050 and, therefore, are not repeated here.

The electrostimulation conductors 10456 in this exemplary embodiment areon opposing sides but they can be disposed at any two (or more)locations about the exterior surface of the earbud core assembly 10450.The conductors 10456 each project entirely through a flange 10458 of theearbud core assembly 10450 to form two rearward projecting extensionsthat can be inserted into respective ones of the bores 10033 when theearbud core assembly 10450 is clocked in the installation position. Asdescribed above, to provide this clocking, the interior surface of thecentral bore 10452 has at least one groove 10753 that extends from therear side of the flange 10458. In contrast to the an open funnel shapenecking down to a shape that exactly matches the exterior shape of theclocking ridges 10038, this groove 10753 has a shape substantiallymatching the groove 10438. Also, in FIGS. 104 to 107, there is only asingle groove 10753, even though more are envisioned. The length thatthe clocking ridge 10438 extends away from the flange 10032 of thespeaker housing stud 10030 is set so that the rearward projectingextensions of the conductors 10456 (e.g., bottom of FIG. 107) areprevented from coming into contact with the flange 10032 unless anduntil the clocking ridge 10438 is within the groove 10753 of the centralbore 10452. In this way, the conductors 10456 automatically andassuredly enter the bores 10033 and make electrical contact with theleads 8118. The conductors 10456 are shown as round wires but they canbe of any polygonal shape, including hexagonal, triangular, and square,for example.

As shown especially in FIGS. 105 and 107, the conductors 10456 use theirshape to remain fixed on the body of the earbud core assembly 10450.From the earbud side of the earbud core assembly 10450, the conductors10456 reside in a circumferential groove within the central bore 10452to have the core-assembly stud 10034 trap the conductors 10456 thereinwhen the core assembly 10030 is installed within the earbud coreassembly 10450. The conductors 10456 then radially pass outwards throughthe material of the stud 10457 to exit at the outer surface and travelcircumferentially along a portion of the outside surface of the stud10457. When transitioning from the interior of the stud 10457 to theexterior, the conductors 10456 can make a 180-degree bend or can make anS-like bend. The conductors 10456 then make a 90-degree bend away fromthe direction of the earbud 10060 and travel along a longitudinal lengthof the stud 10457 in a groove that keeps the conductors 10456 restingtherein but still projecting out from the outer surface of the stud10457. The conductors 10456 then bend approximately 90 degrees radiallyoutwards and then 90 degrees rearward to project through the flange10458 and extend out the rear side thereof. To make contact withconductive surfaces 10062, 10064 of the earbud 10060, it is importantfor the conductors 10456 to protrude from the outer surface of the stud10457. In this regard, any part or all of the portion of the conductors10456 that extend along the exterior of the stud 10457 can be bentoutwards to produce a bias that insures conductive connection toconductive interior surfaces 10062, 10064 of the earbud 10060 or aportion can be made thicker in a radially outwards direction.

Other different embodiments for making electrical contact between theelectrostimulation conductors and the electrostimulation leads 8118 areshown in FIGS. 108 to 112. In particular, FIGS. 108 to 111 illustrate anembodiment of an earbud core assembly 10850 that has a stud 10857 withan ovular exterior shape instead of circular. In this exemplaryembodiment, it is the shape of the stud 10857 that provides the clockingfeature, thereby making the clocking bosses/grooves unnecessary. InFIGS. 109 and 111, the conductors 10956 are wires having a polygonalshape. In contrast. FIGS. 108 and 110 show the conductors as beingattached to the exterior and extending away from the surface of the stud10857. Like the previous embodiments above, the embodiment of an earbudcore assembly 11250 in FIG. 112 has a circular stud 11257. Theconductors 11256, in contrast, have circumferential extents attached tothe exterior of the stud 11257 at different longitudinal lengths alongthe circular stud 11257 that do not circumferentially overlap oneanother. Likewise, the interior conductive portions 11262, 11264 of theconducting sections 10062, 10064 of the earbud 10060 extend into theinterior core of the earbud 10060 at different lengths so that there isonly one orientation that successfully makes electrical contact. It isnoted that this embodiment allows for a small range of clocking of theearbud core assembly 11250 to the earbud 10060, which range is definedand delimited by the size of the gap 11201 between each of thecircumferential extents of the conductors 11256.

FIG. 113 depicts a third exemplary embodiment of a stand-aloneelectrostimulation earbud 11300. The strain relief, speaker housing,speaker housing stud, speaker assembly, and ear bud are all similar inthis embodiment and, therefore, will not be described in further detailas the descriptions herein are applicable to the instant embodiment.What is different is the earbud core assembly 11350. In the particularexemplary embodiment of FIGS. 113 to 115, the portion of the earbud coreassembly 11350 that is different is how the electrostimulationconductors 11356 travel and are attached to the stud 11357 of the earbudcore assembly 11350. With this one exception, all other attributes ofthe earbud core assembly 11350 are similar to at least the earbud coreassembly 10050 and, therefore, are not repeated here.

The electrostimulation conductors 11356 in this exemplary embodiment areon opposing sides but they can be disposed at any two (or more)locations about the exterior surface of the earbud core assembly 11350.Instead of a single conductor projecting entirely through the flange11358 of the earbud core assembly 11350 to form the two rearwardprojecting extensions that can be inserted into respective ones of thebores 10033 when the earbud core assembly 10450 is clocked in theinstallation position, here, each conductor is formed from a set of twoparts. A first part 11356′ of each of the two-part conductors 11356 issurface conducting plate having a curved shape corresponding to theouter circumference of the stud 11357 and having a 90-degree bentportion that is shaped to abut the flange 11358. This bent portion has athroughbore that receives the second part 11356″ of the conductor 11356,which is a pin or nail that pierces the throughbore and the flange 11358to secure the first part to the earbud core assembly 11350. The ends ofthe pins are the conductive portions that enter the bores 10033 and makeconductive contact for receiving the electrostimulation. As describedherein, to provide clocking, the interior surface of the central bore11352 has at least one groove that extends from the rear side of theflange 11358. As in other embodiments, the length that the clockingridge 10438 extends away from the flange 10032 of the speaker housingstud 10030 is set so that the rearward projecting extensions of theconductors 11356 are prevented from coming into contact with the flange10032 unless and until the clocking ridge 10438 is within the groove ofthe central bore 11352. In this way, the conductors 11356 automaticallyand assuredly enter the bores 10033 and make electrical contact with theleads 8118. The pins 11356″ of the conductors 11356 are shown as roundbut they can be of any polygonal shape, including hexagonal, triangular,and square, for example.

The embodiments shown in FIGS. 100 to 107 and 113 to 115 house arectangular shaped speaker assembly 10040. Another kind of speakerassembly is one that is coin-shaped, these structures are round and havediameters of between 8 mm and 16 mm. The following embodimentsillustrate earbud-type neurostimulator devices that house suchcoin-shaped speaker assemblies. Some of the features that are present inthese embodiments are substantially similar to ones in previousembodiments and, in such cases, will have the same or similar referencenumerals. Other features may be similar but new reference numerals areused to identify the features in these embodiments. Such differences,however, does not mean that the features cannot be combined or exchangedwith other similar features described above or below. Indeed, anyfeature of one embodiment can be and is considered to be interchangeableand/or combinable as one of ordinary skill in the art would make suchchanges or combinations.

FIG. 116 depicts a first exemplary embodiment of a stand-aloneelectrostimulation earbud 11600 for a coin-shaped speaker assembly.Starting from the bundle of electrical leads, including two 8110 for thespeaker and two 8118 for the electrostimulation signal, a strain relief11610 guides the leads into a speaker housing 11620 and is fixed withinan entry port 11622. The speaker housing 11620 is semi-rigid and can bemade of plastic, for example, ABS. The speaker housing 11620 can be 3Dprinted if desired and forms an encasement for a device that holds aspeaker therein. In particular, an internal hollow of the speakerhousing 11620 receives a portion of a speaker housing stud 11630, inwhich is held a speaker assembly 11640 (depicted with dashed lines). Anoverall length of the speaker housing stud 11630 is approximately 15 mmand an outer maximum diameter is about 13 mm. The exemplary embodimentof the speaker housing stud 11630 shown in FIG. 116 is shaped to hold acoin-shaped speaker assembly 11640 that is approximately 10 mm indiameter. Thus, the outer diameter of the speaker housing 11620 can beas little as about 12 mm but, here, is about 13 mm. The speaker leads8110 (depicted with dashed lines) pass through the interior of thespeaker housing 11620 and are electrically connected to the speakerassembly 11640. Connection of the electrostimulation leads 8118 will beexplained below. Finally, the rear of the speaker housing 11620 can beshaped to provide a space for a decal or sticker printed with atrademark thereon or the space can form the logo itself, for example, byraised bosses or lowered channels.

When installed at the speaker housing 11620, the speaker housing stud11630 has a flange 11632 that, together with the strain relief 11610 andthe speaker assembly 11640, substantially seals off the interior of thespeaker housing 11620 from the environment. At its rear side, thespeaker housing stud 11630 has speaker arms 11633, best shown in FIG.117, that securely holds the speaker assembly 11640 therebetween. At itsfront or earbud side, the speaker housing stud 11630 has a core-assemblystud 11634. The speaker housing stud 11630 has various features. First,sound from the speaker assembly 11640 needs to be communicated to theuser. In the particular exemplary embodiment of FIGS. 116 to 118, theinterior hollow of the core-assembly stud 11634 forms a sound channelthat communicates sound from the speaker assembly 11640 to the user'sinner ear. A second feature holds an earbud core assembly 11650 to thespeaker housing stud 11630 when the earbud core assembly 11650 isconnected thereto. In the particular exemplary embodiment of FIGS. 116to 118, the flange 11632 of the speaker housing stud 11630 has twowindows 11638 that removably receive tabs 11652 therein when the earbudcore assembly 11650 is installed on the core-assembly stud 11634. Thesewindows 11638 clock the earbud core assembly 11650 to a pre-setinstallation orientation. In the particular exemplary embodiment ofFIGS. 116 to 118, there are two windows 11638 but there can be anynumber of windows 11638 and tabs 11652, for example, from one to five.This clocking feature will be described in further detail below.

The speaker housing stud 11630 has two electrical contacts that providean electrical conduit for electrostimulation arriving through theelectrostimulation leads 8118. As explained in the embodiments herein,this conduit can take various forms. One exemplary configuration for theelectrostimulation leads 8118 shown in FIGS. 116 to 118 is a set ofelectrically conductive strips 11636 each respectively extending fromone of the arms 11633 on the speaker housing (or rear) side of theflange 11632. Each lead 8118 is connected to a strip 11636 at the rearside of the flange 11632 in any way, for example, by soldering. Eachstrip 11636 extends towards the earbud 11660 on the outer surface of thearm 11633, across the flange 11632, inwardly to the core-assembly stud11634, and then along the outer surface of the core-assembly stud 11634to a given extent sufficient to oppose a window on the earbud coreassembly 11650 that is described in further detail below. The strips11636 can be attached to the speaker housing stud 11630 in a variety ofways, some of which are described herein. They can be attached using anadhesive. They can be a liquid that is painted on the surface. Thestrips 11636 can be formed in the same manufacturing process thatcreates the speaker housing stud 11630 itself. To make contact withconductive surfaces 11662, 11664 of the earbud 11660, the conductivestrips 11636 can be made to protrude from the outer surface of theearbud core stud 11634. In this regard, any part or all of the portionof the conductive strips 11636 that extend along the exterior of theearbud core stud 11634 can be bent outward or produced thicker to insureconductive connection to conductive interior surfaces 11662, 11664 ofthe earbud 11660.

The earbud core assembly 11650 is semi-rigid and can be made of plastic,for example, ABS. The earbud core assembly 11650 can be 3D printed ifdesired and forms the structural support for the earbud 11660. Theearbud core assembly 11650 also possesses various features. First, theearbud core stud 11656 has a central bore 11654 that receives thecore-assembly stud 11634 therein. The two studs are sized to not havethe distal end of the core-assembly stud 11634 protrude from the distalend of the earbud core assembly 11650; although, if desired, the distalend can protrude therefrom. It is noted that the earbud 11660 isenvisioned to be a disposable part and, therefore, must be replaced(although it can be reusable). Thus, it must be able to be removed fromeither or both of the speaker housing stud 11630 and the earbud coreassembly 11650. If desired, the earbud core assembly 11650 can also bedisposed with the earbud 11660 or it can be retained for use with areplacement earbud 11660.

The earbud core assembly 11650 does not possess any part of theelectrostimulation conductors. Instead, in this exemplary embodiment,the earbud core stud 11656 provides windows that, allow conductivebosses (e.g., 16301, 16501) on the earbud 11660 to pass therethrough andelectrically contact the conductive strips 11636. In this exemplaryembodiment, the windows 11658 are on opposing sides (only one is visiblein FIGS. 116 and 118) but they can be disposed at any two (or more)locations about the exterior surface of the earbud core stud 11634.

The earbud 11660 is the part that provides electrostimulation from thegenerator to the ear canal. In an exemplary embodiment, a body 11666 ofthe earbud 11660 is made of silicone and, therefore, it is flexible andsoft enough to place in a user's ear canal without discomfort. Theearbud 11660 is envisioned to be disposable (although it can bereusable). The earbud 11660 has eight leaves or tines. The number oftines is not significant as long as a first portion of the outer surfaceof the earbud 11660 can conduct one part (positive/negative/ground) ofthe electrostimulation and another different second portion of the outersurface of the earbud 11660 insulated from the first portion can conductthe other part (negative/ground/positive) of the electrostimulation. Inthe embodiment where eight tines are present, an adjacent set of threeof the tines conduct the first part of the signal and an adjacent set ofthree different tines conduct the other part of the signal, the twoindividual remaining tines separating and insulating the two sets ofthree. The earbud 11660 has an interior lumen 11668 that is sized to fitsnugly but removably on the earbud core stud 11656 of the earbud coreassembly 10050 and two opposing earbud bosses (e.g., 16301, 16501)extend radially inwards from the surface of the interior lumen 11668 toproject into and through the windows 11658 and directly contact an outerconductive surface of a respective one of the strips 11636. The bosses(e.g., 16301, 16501) can be of substantially the same shape as thewindows 11658 or they can be smaller.

Conductivity of the tines is provided by coating one of the bosses(e.g., 16301, 16501) and a portion of the interior lumen 11668 with aconductive material and extending that coating around the end of thelumen (to the right in FIG. 116) and onto, for example, the first set ofthree tines to form the first conductive surface 11662. Similarly, theother of the bosses (e.g., 16301, 16501) and a portion of the interiorlumen 11668 adjacent the other boss (e.g., 16301, 16501) is conductivelycoated and the coating is extended around the end of the lumen and onto,for example, the second set of three tines to form the second conductivesurface 11664. One way to apply this coating is with an adhesive tapemanufactured by 3M, the tape having a conductive surface on one side anda silicone adhesive on the other, although other methods and devices,some of which are mentioned herein, are equally applicable as well. Adepth of the interstices between tines can be, for example, betweenapproximately 1 and 4 mm.

With such a configuration, the windows 11658 of the earbud core stud11656 provide both clocking and securing features for the earbud 11660to insure that the earbud is fixed for use as well as making electricalcontact with the strips 11636. In this way, the conductive bosses (e.g.,16301, 16501) on the earbud 11660 automatically and assuredly enter thewindows 11658 and make electrical contact with the leads 8118.

FIG. 119 depicts a second exemplary embodiment of a stand-aloneelectrostimulation earbud 11900 for a coin-shaped speaker assembly. Thestrain relief, speaker housing, speaker assembly, and ear bud are allsimilar to the embodiment of FIG. 116 and, therefore, will not bedescribed in further detail as the descriptions herein are applicable tothe instant embodiment. What is different is the speaker housing stud11930 and the earbud core assembly 11950 (and the speaker housing 11920is slightly smaller). In the particular exemplary embodiment of FIGS.119 to 121, the speaker housing stud 11930 is sized for an 8 mmcoin-shaped speaker assembly 11940. The speaker housing stud 11930 canbe made of ABS, for example, and has an overall length of approximately15 mm and an outer maximum diameter of about 11.5 mm, thus, as comparedto the embodiment of FIG. 116, the speaker housing 11920 can be madesmaller, as shown in the comparison of FIGS. 122 and 123, where theembodiment of FIG. 116 is shown in FIG. 122 and the embodiment of FIG.119 is shown in FIG. 123. With these differences, other attributes ofthe speaker housing stud 11930 are similar to at least the speakerhousing stud 11630 and other attributes of the earbud core assembly11950 are similar to at least the earbud core assembly 11650 and,therefore, they are not repeated here.

When installed at the speaker housing 11920, the speaker housing stud11930 has a flange 11932 that, together with the strain relief 11910 andthe speaker assembly 11940, substantially seals off the interior of thespeaker housing 11920 from the environment. At its rear side, thespeaker housing stud 11930 has speaker arms 11933 (see also FIGS. 120and 121) that securely hold the speaker assembly 11940 therebetween. Atits front or earbud side, the speaker housing stud 11930 has acore-assembly stud 11934 with an interior hollow forming the soundchannel that communicates sound from the speaker assembly 11940 to theuser's inner ear. The speaker housing stud 11930 has two electricalcontacts that provide an electrical conduit for electrostimulationarriving through the electrostimulation leads 8118. One exemplaryconfiguration for the electrostimulation leads 8118 shown in FIGS. 119to 121 is a set of electrically conductive strips 11936 eachrespectively extending from one of the arms 11933 on the speaker housing(or rear) side of the flange 11932. Each lead 8118 is connected to astrip 11936 at the rear side of the flange 11932. Each strip 11936extends towards the earbud 11960 on the outer surface of the arm 11933,across the flange 11932, inwardly to the core-assembly stud 11934, andthen along the outer surface of the core-assembly stud 11934 to a givenextent sufficient to oppose the window 11958 on the earbud core assembly11950. The earbud core assembly 11950 has an earbud core stud 11956 witha central bore 11954 that receives the core-assembly stud 11934 therein.

FIG. 124 depicts a third exemplary embodiment of a stand-aloneelectrostimulation earbud 12400 for a coin-shaped speaker assembly. Ascompared to other exemplary embodiments, here, the earbud core assemblyhas been eliminated. In particular, starting from the bundle ofelectrical leads, including two 8110 for the speaker and two 8118 forthe electrostimulation signal, a strain relief 12410 guides the leadsinto a speaker housing 12420 and is fixed within an entry port 12422.The speaker housing 12420 is semi-rigid and can be made of plastic, forexample, ABS. The speaker housing 12420 can be 3D printed if desired andforms an encasement for a device that holds a speaker therein. Inparticular, an internal hollow of the speaker housing 12420 receives aportion of a speaker housing stud 12430, in which is held a speakerassembly 12440. An overall length of the speaker housing stud 11630 isapproximately 15 mm. The exemplary embodiment of the speaker housingstud 12430 shown in FIG. 124 is shaped to hold a coin-shaped speakerassembly 12440 that is approximately 8 mm in diameter. Thus, the outerdiameter of the speaker housing 12420 can be as little as about 11.5 mm.The speaker leads 8110 pass through the interior of the speaker housing12420 and are electrically connected to the speaker assembly 12440.Connection of the electrostimulation leads 8118 will be explained below.Finally, the rear of the speaker housing 12420 can be shaped to providea space for a decal or sticker printed with a trademark thereon or thespace can form the logo itself, for example, by raised bosses or loweredchannels.

When installed at the speaker housing 12420, the speaker housing stud12430 has a flange 12432 that, together with the strain relief 1410 andthe speaker assembly 12440, substantially seals off the interior of thespeaker housing 12420 from the environment, which is shown in FIG. 125.At its rear side, the speaker housing stud 12430 has speaker arms 12433,best shown in FIG. 126, that securely hold the speaker assembly 12440therebetween, while also providing a surface for the conductive materialthat passes the electrostimulation signal from the wire to the earbuds,as will be described below. At its front or earbud side, the speakerhousing stud 12430 has a earbud stud 12434. The speaker housing stud12430 has various features. First, sound from the speaker assembly 12440needs to be communicated to the user. In the particular exemplaryembodiment of FIGS. 124 to 129, the interior hollow of the earbud stud12434 forms a sound channel 12435 that communicates sound from thespeaker assembly 12440 to the user's inner ear. A second feature holdsan earbud 12460 to the speaker housing stud 12430 when the earbud 12460is connected thereto. In the particular exemplary embodiment of FIGS.124 to 129, the earbud stud 12434 has two windows 12438 that removablyreceive bosses (e.g., 16301, 16501) therein when the earbud 12460 isinstalled on the earbud stud 12434. These windows 12438, therefore,clock the earbud 12460 to a pre-set installation orientation and, at thesame time, provide electrical contact between the leads 8118 and theexternal conductive surfaces 12462, 12464 of the earbud 12460. In theparticular exemplary embodiment of FIGS. 124 to 129, there are twowindows 12438 but there can be any number of windows 12438. Thisclocking feature will be described in further detail below.

The speaker housing stud 12430 has two electrical contacts that providean electrical conduit for electrostimulation arriving through theelectrostimulation leads 8118. As will be explained in the embodimentsherein, this conduit can take various forms. One exemplary configurationfor the electrostimulation leads 8118 shown in FIGS. 124 to 129 is a setof electrically conductive strips 12436 each respectively extending fromone of the arms 12433 on the speaker housing (or rear) side of theflange 12432. These strips are shown separated from the speaker housingstud 12430 in FIG. 129. Each lead 8118 is connected to a strip 12436 atthe rear side of the flange 12432 in any way, for example, by soldering.Each strip 12436 starts extending in a direction orthogonal to the arms12433 at the speaker housing side thereof and then bends 90 degrees totravel along the longitudinal length of the arm 12433 on the exteriorsurface thereof. At the earbud side of the flange 12432, the strip 12436bends radially inwards and travels along the side of the flange 12432until another 90 degree bend has the strip 12436 travel along theexterior surface of the earbud stud 12434. To assist in securing thestrip 12436 at the speaker housing stud 12430, the earbud stud 12434 isprovided with ports 12437 extending from the interior channel 12435through to the environment into which distal tips of the strip 12436extend to rest against the interior surface of the channel 12435 (seeFIGS. 127 and 128). In this regard, the distal tip of the strip 12436forms an S-bend as shown in FIG. 129. The channel 12435 of the earbudstud is formed with cavities in which rest respective distal tips of thestrips 12436 when the strips 12436 are installed, these cavities beingshown best in the right side of FIG. 126.

These strips 12436 extend along the outer surface of the earbud stud12434 to a given extent sufficient to connect conductive surfaces on theinner lumen of the earbud 12460. The strips can be attached to thespeaker housing stud 12430 in a variety of ways. They can be attachedusing an adhesive and/or the form of the strips 12436 can provide all ofthe retaining force. To make contact with conductive surfaces 12462,12464 of the earbud 12460, the conductive strips 12436 can be made toprotrude from the outer surface of the earbud stud 12434. In thisregard, any part or all of the portion of the conductive strips 12436that extend along the exterior of the earbud stud 12434 can be bentoutward or produced thicker to insure conductive connection toconductive interior surfaces 12462, 12464 of the earbud 12460.

Significant in this exemplary embodiment is that there is no earbud coreassembly, thereby eliminating an entire part; the earbud 12460 directlyconnects to the earbud stud 12434.

The earbud 12460 is the part that provides electrostimulation from thegenerator to the ear canal. In an exemplary embodiment, the main body ofthe earbud 12460 is made of silicone or similar pressure-deformableplastics, rubbers, or polymers, and, therefore, it is flexible and softenough to place in a user's ear canal without discomfort. The earbud12460 may be disposable or reusable. In this exemplary embodiment, theearbud 12460 has no tines or any elements of the outer surface that aremechanically isolated or independent from each other, but have acontiguous outer surface and formed as a portion of a prolate spheroidwith a central bore 12668. As such, two portions 12462, 12464 of theouter surface of the earbud 12460 are electrically conductive andintervening portions 12466 electrically insulate the two portions 12462,12464 from one another. The number of electrically independentconductive portions is not significant as long as a first portion of theouter surface of the earbud 12460 can conduct one part(positive/negative/ground) of the electrostimulation and anotherdifferent second portion of the outer surface of the earbud 12460insulated from the first portion can conduct the other part(negative/ground/positive) of the electrostimulation. As such any formor shape of the portions 12462, 12464 is possible, such as FIGS. 83 to90. For example, each tine can have its own electrostimulation signalthat is independent from other signals going to other tines, each ofwhich is its own independent electrostimulation circuit and one tine canbe a common ground or ground can be placed on another portion of theuser's skin that has sufficient conductivity. Alternatively, each ofthese independent electrostimulation circuits can have their own uniqueground to form separate electrostimulation sets on a single earbud.

In yet other embodiments, the earbud has only one conductive element,with the other (negative/ground) located anywhere else on the body aslong at the contact area has sufficiently low resistance for conductionto occur. The earbud 12460 has an interior lumen 12468 that is sized tofit snugly but removably on the earbud stud 12434 and possesses twoopposing earbud bosses (e.g., 16301, 16501) extending radially inwardsfrom the surface of the interior lumen 12468 to project into and throughthe windows 12438 and directly contact an outer surface of a respectiveone of the strips 12436. The bosses (e.g., 16301, 16501) can be ofsubstantially the same shape as the windows 12438 or they can besmaller. Such a connection retains the earbud 12460 on the earbud stud12434 until replacement is required.

As consistent, predictable, reliable, comfortable, and secure electrodecontact to the skin is important for reliable and reproducible resultsacross varying ear anatomies, exemplary embodiments of the earbud hereincontain independent, substantially mechanically isolated or partiallymechanically isolated projections or “tines” with sufficiently broadsurfaces that extend outward circumferentially to form an outer contactsurface that is substantially parallel to the body surface targeted forelectrode contact. In these embodiments, the targeted surface is theear, and more specifically, the ear canal. Having separate tines withelectrode surfaces along the outer contact surface allows forindependent contact of small portions of the full ear canal-earbudcontact area to accommodate to a smaller, less variable portions of theear canal. Furthermore, each tine is substantially mechanically isolatedfrom the others so that an ear canal that is not circular (or an earcanal with surface irregularities or inconsistencies in certain areas)will not affect the other tines and will maximize the chance of proper,individual tine contact to smaller, more discreet segments of the earcanal. Although each individual tine contacts less surface area of theear canal, having multiple tines allows for a desired surface area to becontacted by the electrode surfaces. Tines that are in contact with earcanal surface irregularities have a greater chance of making contact tothat area because that tine, or tines, can independently adjust to bestaccommodate contact at that discreet and focal location. In summary,dividing up the outer, radially dispersed contact areas of the earbudinto individual, substantially mechanically independent segments, allowsthe outer perimeter of the earbud to accommodate and replicate thenon-circular and variable nature of ear canal anatomy and, thus, havebetter and more complete contact with the inner surfaces of the earcanal. Furthermore, tines that do not contain electrodes will allow forbetter retention forces to best resist movement of the earbud and ordislodgement. Conductivity of the tine portions is provided by coatingone of the bosses (e.g., 16301, 16501) and a portion of the interiorlumen 12468 distally with a conductive material and extending thatcoating around the end of the lumen (to the right in FIG. 124) and ontoa first electrode area to form the first conductive surface 12462.Similarly, the other of the bosses (e.g., 16301, 16501) and a portion ofthe interior lumen 12468 adjacent the other boss (e.g., 16301, 16501) iscoated and extended around the end of the lumen and onto the secondelectrode area to form the second conductive surface 12464. One way toapply this coating is with an adhesive tape manufactured by 3M, the tapehaving a conductive surface on one side and a silicone adhesive on theother, although other methods, conductive materials, and devices areequally applicable as well, some of which have been described herein.

With such configuration, the windows 12438 of the earbud stud 12434provide both clocking and securing features for the earbud 12460 toinsure that the earbud is fixed for use as well as making electricalcontact with the strips 12436. In this way, the conductive bosses on theearbud 12460 automatically and assuredly enter the windows 12438 andmake electrical contact with the leads 8118 and do not have any chanceof damaging the conductive connection between the earbud 12460 and thestrips 12436.

FIGS. 130 and 131 diagrammatically illustrate a fourth exemplaryembodiment of a stand-alone electrostimulation earbud 13000 for acoin-shaped speaker assembly. Depicted is the speaker assembly 13040,the speaker housing stud 13030 with arms 13033, the earbud core assembly13050, and the conductive strips 13036. In this embodiment, the twoconductive strips 13036 connecting to the leads 8118 for theelectrostimulation extend out from windows 13058 of the earbud core stud13056 of the earbud core assembly 13050 instead of just residing at thebottom of the windows 11658, as depicted in FIG. 116, for example. Inall other respects, this configuration is similar to at least theconfiguration of FIGS. 116 to 118 and, therefore, explanation of theother items is not repeated here.

FIGS. 132 to 135 diagrammatically illustrate a fifth exemplaryembodiment of a stand-alone electrostimulation earbud 13200 for acoin-shaped speaker assembly 13240. Depicted is the speaker assembly13240, the speaker housing stud 13230 with arms 13233, and theconductive wires 13236. In this embodiment, the two conductive wires13236 connecting to the leads 8118 for the electrostimulation extend toa conductive coating of the earbud 13260 instead of to the speakerhousing stud 13230. Significantly, this embodiment does not require anearbud core assembly and, in contrast to other embodiments, theconducting path of the strips 13236 do not contact the earbud stud13234. Instead, a conducting wire simply passes around the flange 13232and connects to a conductive part 12361 within the earbud 13260 (e.g.,within one of the tines), which, in turn, is conductively connected to aconductive area 13262 on the outside of the earbud 13260. Thisconfiguration helps retain the earbud 13260 in place and avoids havingto make any part of the inner lumen of the earbud 13260 conductive,which could be difficult, complicated, and/or time-consuming. In allother respects, this configuration is similar to other describedconfigurations herein and, therefore, explanation of other features isnot repeated here.

The signal generation and transmission architecture for theelectrostimulation is not limited to one possible configuration. A firstexemplary architecture 13600 is described with regard to FIG. 136. Inthis first configuration, signal generation and electrode controlresides in a first location/device and electrostimulation signaldelivery and optional sensing resides in a separate location/device. Thetwo locations being electrically connected by at least one transmissionconduit 13610. The generator 13601 contains a power supply 13620, apower switch 13630, user inputs 13640, a controller or control logic13650, user I/O devices 13660, and an electrostimulation drive circuit13670. The controller/control logic 13650 is supplied with power throughthe power supply 13620 and is controlled through the power switch 13630.The power supply 13620 contains any combination of a non-rechargeablebattery (such as a 9V), a rechargeable battery, a charging circuit,and/or a parasitic power input system. The power switch 13630 containsany combination of a physical switch, a biometric switch, and a sequenceof use action (i.e., connecting a device coupler to an external powersource turns on the generator 13601).

User input 13640 or I/O devices 13660 provide the interface between theuser and the controller 13650 and are connected to the controller 13650,provide the controller 13650 with user input, and provide the user withfeedback in the form of various types of information. The I/O devices13660 give the user the ability to set parameters such as, but notlimited to, amplitude of electrostimulation. The I/O devices 13660include, for example, a scroll wheel, a collection of buttons, lights(e.g., LED), a speaker(s), and/or a display (e.g., LCD, LED). Sensors13680, which are optional, can include a heart rate monitor, aphysiologic feedback device, or any other system that gives informationto a user. The I/O devices 13660 can display to the user a status of thegenerator 13601, settings of the device, and other information.

The controller 13650 controls the drive circuit 13670, which, in turn,provides the electrodes 13690 with neurostimulation through the at leastone transmission conduit 13610. The controller 13650 receives input fromthe user and the sensor(s) 13680 in the device coupler 13602 and outputsstimulation parameters to the drive circuit 13670. The drive circuit13670 converts signals from the controller 13650 into electrostimulationat a desired/required power/frequency/amplitude level. The drive circuit13670 can include a pulse circuit and provide a voltage step-up, forexample.

The sensor(s) 13680 of the device coupler 13602 allows for closed loopstimulation control and provides control for a user feedback system. Thesensors 13680 or sensor system(s) communicate information to controllogic 13650 to maintain a closed loop control on a desired stimulationsignal. The sensors 13680 can be isolated sensors or part of theelectrodes 13690. Impedance, temperature, electrode separation, tissueO₂ concentration, physiologic sensing, capacitance, EEG, heart rate, andperspiration level are among the possible exemplary sensor inputs.

The transmission conduit 13610 in an exemplary embodiment is a wiredconnection between the generator 13601 and the device coupler 13602. Asused in the exemplary architectures described herein, however,electrical connection by the transmission conduit(s) 13610 can be wired,wireless, or both. The transmission conduit 13610 is able to handle ahigher potential difference than only a logic voltage. It is eitherintegrated or is detachable.

The device coupler 13602 contains the electrodes 13690, the sensors13680, or both. The electrodes 13690 provide the conductive points thatcontact an electrostimulation area for use of the device.

A second exemplary architecture 13700 is described with regard to FIG.137. In this second configuration, the system is fully integrated withsignal generation, electrode control, and signal delivery and sensingresiding in a single location/device. For example, the system can beakin to an over-the-ear hearing aid. All of the features of FIG. 136 areequally applicable to this configuration and, therefore, they are notrepeated. In this exemplary architecture, thegenerator/controller/coupler 13700 contains each of the power supply13620, the controller/control logic 13650, the drive circuit 13670,provides the options for user input 13640, provides user feedback 13660,and has the power switch 13630, the sensors 13680 (if any), and theelectrodes 13690.

A third exemplary architecture 13800 is described with regard to FIG.138. In this third configuration, the system integrates the generatorand device coupler into a personal smart device (PSD) application to beimplemented by a PSD (e.g., a smart phone, a smart watch, a tablet, alaptop computer, a desktop computer). The generator and controller,therefore, can mostly be formed from software. The PSD application can,in an exemplary embodiment, integrate the neuromodulation devicestimulation with onboard audio of the PSD (which can include music,white noise, an audio book, auditory pre-set patterns, or any otherdesired sounds). All of the features of FIGS. 136 and 137 that areequally applicable to this configuration are not repeated.

The PSD provides all of the user input 13640, the processing 13650, theuser feedback 13660, and other capabilities and allows all of the PSD'sfeatures to be used as well and in conjunction with the PSD. TheGenerator-and-Device Coupler (GDC) converts signals from the controller13650 (e.g., PSD) to stimulation at a desired/required power level. Inthis configuration, therefore, the communications conduit 13610 is alogic level connection between the PSD and the GDC. The conduit 13610can be wired (fixed or detachable) or wireless (TX/RX needed on PSD andGDC) using proprietary systems or standards such as Bluetooth, Wi-Fi,and RF, for example. The user input 13640 can be input methods providedby the PSD or input methods otherwise integrated into the system, andthe user feedback 13660 can be provided by the PSD or otherwiseintegrated into the system. As the power requirements forelectrostimulation are higher than most hand-held PSDs can providereasonably, it can be beneficial to provide, at the device coupler, allof the electrostimulation circuitry, including the power supply 13620,the power switch 13630, and the drive circuit 13670, in addition to theelectrodes 13690 and sensors 13680 (if any). In other embodiments, thedevice is made up of a power supply or a connection to accommodate apower supply (if the device uses power from another device or source), awireless receiver enabling the device to receive and transmit data froma PSD, a generator that can be directed by the PSD through an app togenerate a custom signal that has a specific therapeutic benefit, and apatient coupler to deliver the electrical signal to the user. Thegenerator has the ability to interpret the signal instructions from thePSD and the app to direct the generator to deliver a specificwavelength, pulse width, wave shape, amplitude, and amplitude modulationpattern as specifically directed. As research continues and theunderstanding of neuromodulation progresses, new and unique electricalsignals may be discovered to expand uses and effects on the brain andbody of the user of this technology. This embodiment, therefore, allowsthe user to have a device with its own power supply (that has or doesnot have embedded neuromodulation signal algorithms in its memory) andcan be used to generate a customized therapeutic signal that is directedfrom an app contained within a PSD. Because such apps are ubiquitouswhen it comes to signal output, the app is able to be updated with newand unique instructions that direct the generator to deliver signalsexactly as proscribed by the app and the PSD. In the simplest form ofthis embodiment, the device is made up of two wireless, self-containedearbuds, each individually containing its own power source. One or bothof the earbuds contains a patient coupler with associated electrodes, aswell as a pulse generator and a wireless receiver that receivesinformation from a PSD to deliver a custom signal or the signal can besynchronized to a sound source that can originate from the same PSD,from another PSD, or from ambient sound or music. The PSD contains anapp that serves as the user interface as well as a source of variouselectromodulation algorithms that direct the generator to produce theform of the electrical signal desired.

A fourth exemplary architecture 13900 is described with regard to FIG.139. In this fourth configuration, the system is similar to the firstexemplary architecture 13600 in FIG. 136, but adds an integrated audiosynchronization capability. Included in this architecture 13900 is anaudio source 13902 and a communications conduit 13904 that suppliesaudio signals to audio logic 13906 within the generator and controller.The audio logic 13906 controls signals conveyed through the conduit13904 to a speaker 13908 within the device coupler (e.g., speakerassembly 10040, 11640, 11940, 12440, 13040). Any audio source ispossible, including such devices as a PSD, a cellphone, an MP3 player, acar stereo, a microphone, and/or an audio input from a person on a stageor in a sound booth. The audio conduit 13904 can be a wired or wirelessconnection (e.g., Wi-Fi, Bluetooth, or other methods). No conduit isneeded if the audio source is directly received by the device, forexample, where a built-in microphone is present (e.g., as part of theaudio logic 13906). The audio logic 13906 receives an audio input signaland processes the signal into a form the control logic 13650 canutilize. The audio logic 13906 and/or the control logic 13650 alsoprovide output to an optional speaker 13908, which translates the signalfrom the audio logic 13906 into audible sound that is provided inconjunction with electrostimulation. An exemplary embodiment ofinterfaceable electrostimulation device (I-Estim) may have its own userinterface 13640/13660 and/or can be overridden or augmented byinterfacing it with a smartphone or the like. As above, theelectrostimulation circuitry includes the power supply 13620, the powerswitch 13630, and the drive circuit 13670. In addition to the speaker13908, the device coupler also includes electrodes 13690 and sensors13680 (if any).

Other embodiments of interfaceable electrostimulation devices may nothave a user interface and, instead, may require interfacing with asmartphone, a computer, or the like. A basic example of an I-Estim isone that includes at least one device coupler (e.g., the patientelectrode coupling device) that serves as the terminal interface betweenthe device and the user, a conduit, and a connector device that linksthe conduit to a computer or a smartphone. In this basic example, thecoupler is connected to a computer output port (i.e., a USB port). Thecomputer runs software that serves as the user interface 13640, 13660and directs the user through prompts to determine the user-specificsettings. The computer then generates the signal that is output throughthe USB port into the connector device, travels through the conduit,exits the assembly through the device coupler, and enters the user in alocation that the targeting structure (e.g., earbud) resides. In otherexemplary embodiments, the I-Estim includes its own power source. TheI-Estim may include its own user interface, electronic generatordevices, and embedded software, but is overridden by an externalcomputer device, once connected. Sensing inputs, sensed data processing,algorithms, and measures to respond to algorithms may be solelycontributed by the external computer and are not necessarily required tobe contained in the I-Estim device itself.

As set forth above, the neurostimulation devices can be integrated intoan existing computer or they can be stand-alone devices, or they can besome combination. In some embodiments, the generator can interface witha “smartphone” or computer device or the generator can be a program on asmartphone. In the former example, the generator contains an interfacedevice, such as a plug/jack that is reversibly stowable into thegenerator to protect it while not using the generator or while using thegenerator with a smartphone. This jack, when released from its stowedposition, directly connects with an output interface on the smartphone(e.g., a headphone socket). Alternatively, the plug may include acombined electrostimulation coupler with integrated earbud(s) thatinterface with the generator. This combined configuration allows forconsolidation of the electrostimulation device with the smartphone toallow the user to combine music and electrostimulation simultaneously,even where the electrostimulation signal is not synchronized to themusic. It also consolidates the two devices to be more physicallymanageable for the user. This generator embodiment may be physicallymated to the phone by the electronic interface plug and/or by magneticmeasures, adhesives, clips, hook-and-loop fasteners, or the like toensure that the two devices are reversibly, but durably mated andhandled/carried as a single composite device. Alternatively, thegenerator and controller can be permanently (or temporarily) integratedinto a personal electric device case, such as in the form of asmartphone case. Additionally, or in an alternative to the previouslymentioned smart device integration, the generator, controller, and powersource can be integrated within a battery/charging backup to the smartdevice, which devices can take the form of a piggy-back protective casewith an external battery.

Some of these exemplary configurations of thegenerator/controller/device coupler embodiments are set forth in theembodiments of FIGS. 140 to 143.

A first exemplary configuration for a handheld generator is provided inFIGS. 140 and 141. The generator 14000 contains therein each of thepower supply 13620, the controller/control logic 13650, the drivecircuit 13670, and the audio logic 13906. On the front face of the caseis a power button 13630, a set of user inputs 13640 (including, forexample, a select button 13641, decrease 13642 and increase 13643buttons, and a selection wheel 13644), and at least one user feedbackdevice 13660 in the form of an LED/LCD screen. An audio speaker can beprovided as well. To display information to a user, the screen can be,for example, a 3-line, 16-character LCD screen, but any other displayscreen is also applicable and envisioned. The display indicates to theuser certain aspects of the generator 14000 depending upon the mode thatis in use, and can provide instructions to the user as well.

The device coupler can be any of the exemplary embodiments describedherein. The transmission conduit 13610 (not illustrated) is to beconnected to the generator 14000 through signal ports shown in FIG. 141and includes, for example, an electrode output port 14101, an audioinput port 14102, and an audio output port 14103. The electrode outputport 14101 supplies the electrostimulation signal to an appropriateconnector of the transmission conduit 13610. The audio input port 14102is an electrical connection that receives an external audio signal(e.g., music) from an external source (e.g., iPhone, iPod, Android,laptop, tablet, computer, or any other digital music player) to be usedalong with or supplemented to the electrostimulation signal transmittedthrough the transmission conduit 13610 to the electrodes 13690 on thedevice coupler (e.g., at the earbuds 8130, 9130, 9430, 9510, 10060,11660, 12460, 13260, 14242, 16100, 16500). The audio output port 14103is the electrical connector that supplies the external audio signalactually received at the audio input port 14102 to the speaker assemblywithin the device coupler. As an alternative to an external source, anintegrated microphone 14104 can receive ambient sound (e.g., music ornature sounds) and supply that ambient sound through the transmissionconduit 13610 to the speaker assembly (e.g., at the earbuds) or to thecontroller 13650 for modulation of the electrostimulation insynchronization with that ambient sound, for example, to pulse theelectrostimulation in sync with a back beat or rhythm of a song that isbeing played in the environment of the user.

Another exemplary embodiment of a stand-alone electrostimulation deviceis shown in FIG. 142. A neurostimulation assembly 14200 in thisembodiment is sized to be used with a mobile device 14210, such as acell phone. The neurostimulation assembly 14200 includes two parts, acomplete electrostimulation subassembly 14220 that has all of thefunctionality of the generator 14000 in FIG. 140, for example, but madein a miniature version and a device coupler 14240. In this embodiment,the electrostimulation subassembly 14220 is shaped to fit inside apocket or holding belt 14232 of an accompanying arm or wristband 14230(the band can be eliminated if desired to just provide a piggy-backholder for the mobile device 14210). The band 14230 also has a pocket orchannel 14234 sized to fit the user's mobile device 14210 therein. Ifthe arm/wristband is removed, the holder 14230 can be a protectivecellphone case that houses the electrostimulation subassembly 14220 in adocking port or pocket.

The device coupler 14240 is, in this exemplary embodiment, aneuromodulation earbud embodiment. A first electrical connector 14244 isthe conduit that provides the neuromodulation signal to the electrodes13690 on the earbuds 14242 by a two-channel electrical connection. If,for example, electrostimulation is to be provided to one of the twoearbuds, then two wires connect the first electrical connector 14244 tothe electrodes on that one earbud. A second electrical connector 14246separate from the first electrical connector 14244 connects the audiospeakers within the earbuds 14242 to supply audio signals theretoreceived directly from the mobile device 14210. This second electricalconnector 14246 can, therefore, be comprised of a standard stereo audiojack. In this embodiment, with the device coupler 14240 directlyconnecting to both the mobile device 14210 and the electrostimulationsubassembly 14220 separately, the generator 14220 is physicallyindependent from the audio signals received from the mobile device14210. Thus, if it is desired to have the mobile device 14210 providecontrol or some other function with the electrostimulation subassembly14220, this is done through a wireless connection, such as Bluetooth orWi-Fi.

In the exemplary embodiment of a neurostimulation assembly 14300 in FIG.143, in contrast, the device coupler 14340 directly connects only to theelectrostimulation subassembly 14320. This means that the mobile device14310 is directly connected only to the electrostimulation subassembly14320. As such, all signals originating from the mobile device 14310must pass through the electrostimulation subassembly 14320. In thisembodiment, therefore, the electrostimulation subassembly 14320 cansupply signals directly to the mobile device 14310 for processing,display, diagnostics, etc., which would allow the mobile device 14310 toact as the I/O display of the electrostimulation subassembly 14320. Theelectrostimulation subassembly 14320 is shown on the front face of themobile device 14310 but it is not limited to this configuration and canbe on the rear face.

It is noted that any of the alternative exemplary embodiments related tothe systems and methods disclosed and envisioned include anelectrostimulation device having its own internal power source, anexternal dedicated power source, or one that derives power parasiticallyfrom another device, which can be directly interfaced with a smartphone,a computer tablet, a laptop, or any other form of device withcomputing/programming such that the computing device can serve as theuser interface, a signal processor, a signal timing device, and to carryout the process as well as modulating the user output signal based uponfeedback from one or more sensor, and or have embedded algorithmsdriving the output signal or signals.

In another exemplary embodiment, the systems and methods herein (e.g.,software and/or hardware) can be configured similar to standard digitalaudio workstations that allow a composer to create music but, at thesame time, they allow the composer to create therapeutic triggers/cues(such as electrostimulation control) during or after song or videocomposition. In other words, the composer can create or “mix” a specificneuromodulation signal in synchronization with the track that is beingcreated. In this way, the composer is able to use the systems andmethods herein to produce an audio file formatted with embeddedelectrostimulation cues/triggers. The analogy of this is like asoundboard engineer mixing another instrument into a composition.Alternately, the systems and methods can produce an independentelectrostimulation cue/trigger file that is to be used along with aparticular composition or just by itself. The systems and methods hereinthen process either the embedded audio file or a combination of theaudio file and the electrostimulation file to allow for manual,semiautomatic, and fully automatic composition of a therapeuticelectrostimulation. In this way, all electrostimulation generatorsdescribed herein can be configured to accept industry standard MIDIfiles that trigger electrostimulation, such as industry standardaudio/visual effects devices.

As set forth herein, electrostimulation can occur dynamically oraccording to a particular pre-set pattern. In the former, acousticsignals from music or the environment, for example, provide the changesto modulate the electrostimulation and, in the latter, a pre-definedprogram or routine provides the changing electrostimulation. FIGS. 144and 145 illustrate an electrostimulation signal graph with a horizontaltime scale and a vertical amplitude scale that can be voltage orcurrent. Shown in the two graphs are pulses having a pulse duration, apulse period, a pulse frequency, a pulse group duration, a dwell offtime, and a constant amplitude. In the exemplary embodiments of FIGS.144 and 145, the amplitude of each pulse is +1, the duration of eachpulse is approximately one eighth of a time unit, the pulse groupduration is approximately one time unit, and the dwell off time isapproximately one time unit. These pulses are shown to be square, butcan also be asymmetric, sinusoidal, sawtooth, or any other analogprofile or combination of the aforementioned patterns. FIG. 145 issimilar to FIG. 144 but the pulses are in an alternate polarity sequencewithin the pulse group duration. In an exemplary embodiment, the timebetween alternation of the pulse polarity can be approximately zero andform a uninterrupted transition between polarities (not illustrated).

FIGS. 146 and 147 illustrate other exemplary embodiments ofelectrostimulation. Here, the signal graph of FIG. 146 has an amplitudemodulation as a sine wave with no pulse group duration or dwell offtime. The modulation reference can be of either a digital or an analogprofile. FIG. 147, in comparison, has a pulse group duration ofapproximately two time units and a dwell off time of approximately twotime units.

FIGS. 148 and 149 illustrate additional exemplary embodiments. FIG. 148is an electrostimulation signal graph with a continuous square wavepulse that has an amplitude governed by a sine wave modulationreference. Pulse polarity is modulated by a modulation referencepolarity. Additionally, the pulse frequency is modulated by theamplitude of the modulation reference profile. When the modulationprofile is at its lowest amplitude, the frequency of correspondingpulses is low and, when the amplitude of the modulation profile ishighest, the frequency of the corresponding pulses is also highest. Incomparison, the electrostimulation signal graph shown in FIG. 149 has aconstant frequency and no polarity group. Here, the pulse length ismodulated by the modulation reference profile. When the modulationprofile is at its lowest amplitude, the length of the correspondingpulses is low and, when the amplitude of the modulation profile ishighest, the length of the corresponding pulses is also highest.

The inventors have discovered that users of the electrostimulationdevices and methods described herein experience various levels ofcomfort and discomfort when receiving the electrostimulation. When thepolarity of the signal does not change and the stimulation is constant,such as the signal shown in FIG. 144, users feel discomfort with lowercurrent amplitudes. On the other hand, when the polarity changes, andespecially when the polarity changes quickly, then, not only can theusers tolerate a significantly higher electrostimulation signal current,they find it pleasant and relaxing, thereby providing the benefits thatsuch electrostimulation devices and methods intend. It has been foundthat the increasing portion of the electrostimulation signal providesthe most pleasurable feeling, such as the period between time units 3and 5 in FIGS. 146 and 149. With regard to FIGS. 144 to 149, time unitsare used because the time scale can be of any length (e.g., μs, ms, s).

Significantly, the systems and methods of electrostimulation describedherein can be customized or even run in real time with audio, such asmusic. Such an exemplary embodiment is depicted in FIGS. 150 and 151,where the audio band amplitude pulse output is modulated. In the exampleof FIG. 150, the pulses are generated as a square wave according to theprocess of the signal graph of FIG. 144, i.e., with a constant polaritysquare wave but, here, with no pulse group duration or dwell off time.The amplitude of the pulses of electrostimulation are modulated by aprofile that is analogous to the amplitude of an audio band. Themodulation can be targeted to a particular portion of the audiospectrum. For example, the modulation can track frequencies betweenapproximately 40 and 100 Hz, in particular, between approximately 60 and80 Hz, thereby providing electrostimulation in synchronization with thebeat of very low bass notes. Alternatively, the modulation can functionas a VU meter to track the audio signal being provided into the system.This tracking will be described in further detail below. In comparisonto FIG. 150. FIG. 151 alternates the polarity of the pulses ofelectrostimulation while synchronizing the pulses to the provided musicaudio file. As indicated above, users of the devices and methods preferreceiving stimulation that alternates polarity and, for the reasonsdescribed below, prefer receiving stimulation that is modulated to musicthat the users like instead of utilizing pre-set modulation programs.

A method for performing electrostimulation with a device according toFIGS. 140 and 141 is now described. With an appropriate power sourcesuch as a 9V battery in place, the power button 13630 is pressed to turnthe generator 14000 on. There are three ports on the top of the device:an electrode port 14101, an audio in port 14102, and an audio out port14103. The device coupler in this exemplary embodiment is the couplershown in FIG. 142. Therefore, the dual electrical connector 14244 (whichcan be a 2.5 mm jack) for the positive and negative leads of theelectrostimulation signal is plugged into the electrode port 14101. Thethree-lead electrical connector 14246 for audio input (which can be astandard 3.5 mm audio jack having separate positive leads and a sharednegative lead) is plugged into the audio out port 14103. In this way,the user has the option of listening to music during therapy, in whichcase, an audio source is plugged into the audio in port 14102 and, likethe audio out port 14013, a standard 3.5 mm audio jack having separatepositive leads and a shared negative lead can be used.

After the generator 14000 turns on, the LCD screen displays a welcomemessage or animation before prompting the user to select a desiredoperating mode. Selection of a mode can be accomplished using thedecrease 13642 and increase 13643 buttons. When the desired mode appearson the display 13660, the select button 13641 can be pressed, or thegenerator 14000 can accept a delay of, e.g., ten seconds toautomatically enter the mode that is presently being displayed. One ofthe modes is an audio mode, of which there are two sub-modes, ambientmode and music mode. Alternating between these two modes can beaccomplished, for example, by plug control, i.e., when an audio sourceis plugged into the audio in port 14102, the device defaults to musicmode. In contrast, when the audio in port 14102 is empty, the deviceautomatically enters ambient mode. Additionally, the user can choose toenter a formula mode. Each of these modes is described in further detailbelow.

Within the audio mode, ambient mode turns on by default when there is nojack within the audio in port 14102. Instead of a direct audio sourceplugged into the device from a music player, the audio on which thetherapy will be based is derived from the user's environment. Ambientmode is ideal for when there is music in the background, as at a musicfestival, a concert, or a day at the park, where the environment'ssounds will be reflected in the user's stimulation. When a jack iswithin the audio in port 15102, music mode turns on by default if audiomode is selected. In music mode, the generator 14000 receives audioinput from a source (e.g., the user's hand-held music player), and thenmodulates the electrostimulation to compliment the audio that is beinginput to the generator 14000 in real time. This mode revolutionizes theway one listens to music and is ideal for when the user wants to listento music and relax at the same time. By matching the electrostimulationcurrent with the user's favorite songs and artists, the generator 14000provides a state of relaxation personal to each individual user'spreferences.

In the formula mode, the user will experience electrostimulation with apreprogrammed algorithm. The user selects a single formula from a set ofdifferent electrostimulation formulas. The screen indicates to the userto select a particular formula, which can be done with the decrease13642 and increase 13643 buttons. This algorithm is stored in anon-illustrated memory of one of the chips of the generator 14000. Anyalgorithm can be programmed to achieve a particular result or effect,for example, relaxation, pain control, euphoria. In an exemplaryembodiment, a first pre-set algorithm will deliver apolarity-alternating signal following a modified square wave pattern.The lowest current output from the generator 14000 is constrained at 0.2mA, determined by the inventors as being a minimum therapeutic currentdose. As described below in further detail, a maximum or ceiling forelectrostimulation intensity is selected during setup prior to theelectrostimulation session and, regardless of the different pre-setalgorithms that can be selected, the user is able to set the maximumintensity of the electrostimulation at any time during the session. Asset forth herein, continued research will generate a betterunderstanding of neuromodulation progresses. If new and uniqueelectrical signals are discovered to expand uses and effects on thebrain and body of the user of this technology, then users will desire toimplement such signals with the generator. Accordingly, an algorithmdelivery circuit can be associated with the generator 14000 and have areceiver (e.g., an antenna and transceiver) allowing an external deviceto communicate with the generator 14000, for example, via Bluetooth orWi-Fi. The algorithm delivery circuit stores any customized algorithmsupplied by the user and includes such stored algorithms in the list ofthe algorithms for the formula mode and is describe in further detailbelow.

Calibrating the generator 14000 is an integral part of ensuring thatelectrostimulation is experienced at its fullest potential. Tounderstand the process of calibration, it is noted that a calibrationlevel chosen is independent of the volume at which the audio is playing.

In music mode, by calibrating the generator 14000 during setup, the usercan adjust how the intensity of the electrostimulation will respond to avariance in the music the user has selected to experience. To startcalibration, a “ceiling” for the intensity level is set and then signalsensitivity is set. The step of selecting the maximum power level orintensity actually sets the maximum current of the electrostimulation.Here, the screen prompts the user to choose a maximum power level orintensity. Based on the discovered therapeutic minimum level for currentof approximately 0.2 mA and the maximum threshold for causing discomfortof approximately 8 mA, the inventors set a range of power levelaccording to Table 1 below and, using increments of 0.2 mA, created aset of forty power levels. These ranges may vary in other embodiments.

TABLE 1 Power Level to Current (mA) Conversion Table Level mA 1 0.2 20.4 3 0.6 4 0.8 5 1.0 6 1.2 7 1.4 8 1.6 9 1.8 10 2.0 11 2.2 12 2.4 132.6 14 2.8 15 3.0 16 3.2 17 3.4 18 3.6 19 3.8 20 4.0 21 4.2 22 4.4 234.6 24 4.8 25 5.0 26 5.2 27 5.4 28 5.6 29 5.8 30 6.0 31 6.2 32 6.4 336.6 34 6.8 35 7.0 36 7.2 37 7.4 38 7.6 39 7.8 40 8.0

By using the decrease 13642 and increase 13643 buttons (or the selectionwheel 13644), the desired power level can be selected. As before,holding down either button will lead to a rapid change. Again, thisvalue can be changed during electrostimulation as well. An exemplarydefault intensity can be set at level 10 (corresponding to 2 mA), butthe user can increase or decrease this number based upon experience. Thepower level desired can be implemented, for example, by pressing theselect button 13641. The desired power level can be selected withouthaving any feedback from the generator 14000. However, in an exemplaryembodiment, the user can be required to place an electrode at thetreatment area (e.g., ear canal) while setting the first maximum powerlevel. In this way, the user can experience what will be felt at thetreatment area during application of the electrostimulation.

Then a sensitivity of the electrostimulation signal is set. The displayprovides a graphic that allows a user to see how sensitivitydecreases/increases based upon the audio signal that is present.Exemplary graphics for adjusting the sensitivity include FIGS. 152 and153. If music mode is selected (there is a jack plugged into the audioin port 14102), then the screen prompts the user to calibrate thegenerator 14000 with the audio source that is currently being played bythe external audio player. First, the user selects a preferred/idealvolume level on the external device being used in conjunction with thegenerator 14000. Then, the user sets the maximum intensity. Then, theuser sets the sensitivity level for that type of music being playedusing the selection wheel 13644 (or the decrease 13642 and increase13643 buttons). It is noted that the sensitivity calibration level canbe changed once electrostimulation has begun. An exemplary default levelfor starting sensitivity calibration with regard to FIG. 153 begins witha sensitivity level equal to the number 0, allowing the user to adjusteither positively (right) or negatively (left). While calibrationoccurs, a needle at which the sensitivity level is currently set can,for example, blink. To set the sensitivity level, the select button13641 can be pressed.

Ambient mode is used when there is ambient sound or music as is the casein a concert or dance club. If ambient mode is selected, the screenprompts the user to calibrate the generator 14000 with the backgroundnoise/music in the environment. Calibration is basically the same as inmusic mode. By calibrating the device during therapy setup, the user canadjust how the therapy's intensity responds to the variance in theenvironment's sounds. Based on the volume level of the ambient sound aswell as the degree of amplitude variation of the sound, the user firstadjusts the maximum current level using the selection wheel 13644 (oreven the decrease 13642 and increase 13643 buttons). The maximum levelcalibration can be changed once electrostimulation has begun.Sensitivity of that maximum intensity is then calibrated. If the graphof FIG. 152 is used, then the bar graph consistently moves with respectto ambient sound intensity, and all the user needs to do is simplyadjust the calibration dial so that the last bar to the right is reachedonly at the most intense portions of the ambient sounds. One exemplarydefault level for starting sensitivity calibration with regard to FIG.152 begins with a sensitivity level equal to at a middle bar (e.g., the8^(th) vertical bar), allowing the user to adjust to the left or right.While calibration occurs, the bars up to which the level is currentlyset can, for example, blink. Alternatively, just the one bar indicatingthe sensitivity level can blink. To set the sensitivity level, theselect button 13641 can be pressed.

Sensitivity calibration establishes a relationship between the intensityof electrostimulation and an intensity of the music or the ambientsounds. A higher level of calibration leads to a higher change inelectrostimulation intensity with regards to music intensity. In otherwords, a higher calibration level means that it takes less of a changein the variance of the music intensity to get the same change invariance of electrostimulation intensity. Simply put, a highercalibration is equivalent to a higher sensitivity level. As such, alower calibration is used if the song being played has highervariability or intensity. An example of this includes songs that shiftfrom a soft pitch to a high rhythmic intensities (deep basses) and do sorelatively quickly (e.g., a drop in base). Exemplary music genres withthis characteristic include heavy metal and EDM. A higher calibrationlevel is selected if the song being played has lower variability orintensity. An example of this includes songs that stay relatively stablein rhythmic intensity, such as the genre of New Age music. The maximumcurrent amplitude set in the first calibration step constrains thecurrent to a user-selected preset maximum amplitude. If the maximumamplitude is reached too frequently, sensitivity may be adjusted to a“less sensitive” setting. This ensures that the user can “feel” thesignal change throughout the full range of the particular piece of musicinput and avoid signal clipping. In contrast, if the user cannotperceive or “feel” the signal variation, then the sensitivity may beincreased. This condition would be more likely in music pieces that havevery little variation in intensity. In the exemplary embodiment, thissensitivity adjustment is performed manually using an analogpotentiometer. However, in other exemplary embodiments, a digitalpotentiometer, or “digipot”, may be used and the sensitivity adjustmentcan be software or firmware controlled to automatically adjust andmaximize the user's ability to “feel” the full range of signal variationregardless of the type of music or sounds being input into the deviceand, therefore, into the user's ear.

After the sensitivity level is set, a bar graph akin to a VU meter willmove dynamically and track the variations of the music or other ambientsound. The user can further adjust the sensitivity to ensure that thefull spectrum of the sound can be “felt” without signal clipping on thehigh end of the intensity spectrum of the sounds. If the level on thesensitivity graph is constantly reaching the maximum value, then signalclipping is most likely occurring, thus requiring a reduction insensitivity. If the level on the sensitivity graph is barely moving, theuser may increase sensitivity to vary the signal to a greater degree andbetter “feel” the signal vary in synchronization with the music orsounds.

Setting maximum current and sensitivity and the reasons behind theserequirements will be discussed in further detail below with regard to anexemplary circuit diagram.

It is noted that power level and calibration do not affect one another.Intensity is solely a maximum power level that is output to theelectrodes. In contrast, calibration determines how often thehigher/highest power levels will occur during a treatment sessions. Forinstance, if the intensity is set at level 10 (2 mA), and thecalibration is set at its maximum level, there will be more instances oflevel 10 power than if the calibration was set at an intermediate orlowest value.

After selecting the desired mode (ambient, music, or formula), thescreen prompts the user to choose a duration of the electrostimulation.The inventors have discovered that a therapeutic range forelectrostimulation duration is between 5 to 45 minutes. Thus, the usercan elect a shortest duration starting at five minutes and a longestduration up to forty-five minutes. For example, a default startingduration can be set to fifteen minutes, with the user adjusting the time(e.g., with five-minute increments) with the decrease 13642 and increase13643 buttons (or the selection wheel 13644), where holding down eitherbutton can lead to a rapid change.

The generator 14000 is now ready to begin electrostimulation treatment.Before starting, the screen can display a countdown to treatmentcommencement. This countdown can occur automatically after the powerlevel is set or it can require actuation of the select button 13641.Electrostimulation then begins. In an exemplary embodiment, the firstfifteen to sixty seconds can be a ramp up period. During the session,the screen can provide a dynamic display of a graphic that tracks theinstantaneous (or almost instantaneous) power level being applied to theelectrodes. At the same time, a countdown clock can be decrementing toprovide a visual cue for the treatment session along with the maximumpower level selected. In this way, if the user decides to change thepower level or duration settings or calibration during treatment, thedisplay can show the new value after that change is made. For example,to change the intensity, the user simply presses the decrease 13642 andincrease 13643 buttons, to adjust the sensitivity, the user can spin thewheel 13644 to a desired location corresponding to the new desiredcalibration setting. It is noted that, during the session, neither themusic nor the electrostimulation treatment session stops while adjustingthese parameters. In an exemplary configuration, however, the sessioncan be paused by pressing the power button 13630 (or even the wheel13644), at which time the screen can indicate a paused status as well asprovide instructions on how to resume (press power button 13630).Alternatively, if the user desires to turn the generator 14000 off,holding down the power button 13630 for a given time (e.g., fiveseconds) can effect this result.

It is noted that the generator 14000 can be turned off at any time withuse of the power button 13630 (e.g., by pressing for five seconds).

Based on the above exemplary configuration, a set of specifications forthe generator 14000 arise. The current can range from approximately 0.05mA to approximately 14 mA with use of a power scale from 1 to 40, forexample. As discussed in more detail below, the voltage of theelectrostimulation treatment ranges from approximately 5 toapproximately 120 Volts because the value is determined by the drivenload.

Unlike a standard resistor, the impedance or resistance of human tissueis highly variable. Not only is it variable from person to person, buttissue resistance can change during any given electrostimulationsession. There are many scenarios when this variability can occur. Ifthe subject sweats and that liquid finds its way into the ear canal,impedance will drop. The electrostimulation itself may cause changes inblood flow to the local tissue surface and, therefore, change impedance.If resistance changes, and voltage remains the same, then the currentimparted to the target structure will vary to an unknown degree and, asa result, can either give too much current or too little, rendering thetherapy ineffective or less effective. In an exemplary embodiment, thegenerator 14000 provides current control by varying the voltagedelivered to the subject within a range that can maintain constantcurrent at a range of known resistances. As the processor senses adecreasing current draw, voltage is increased to maintain the setcurrent. On the other hand, if the processor senses an increasingcurrent draw, then voltage is decreased. This adjustment occurs manytimes a second for constant current control. In one exemplaryembodiment, the processor makes checks on the current and, therefore,opportunities to adjust the current fifty times per second. Fortherapies where even more current variability is required, the currentchecks and opportunities to adjust could be set to 100 times per secondor greater (and vice versa). Other exemplary embodiments maintain apre-set current by intermittently stopping therapy for auser-imperceptible duration of time, while resistance between electrodesis measured and voltage is adjusted. The frequency of these resistance“checks” depends on what the therapy is being performed. Waveformshapes, polarities, pulse durations, time between opposite polarities,and frequencies are either completely or partially preset at fixedvalues or may vary during certain therapies for specific indications,may vary only from one therapy indication to another, or may be dictatedby an app on a PSA. Exemplary ranges of values are shown in Table 2below.

TABLE 2 Control Pulse Variables Values Method Current 0.05-14 mA Usersetting Voltage 0.01-16 V Load driven Waveform Modified square wave, sawPreset tooth, square wave, analog waveforms, or combinations thereofPolarity Positive, Negative, Alternating Preset Pulse Duration 1-1000 μsPreset Time Duration Between 0 second minimum to 5 seconds PresetOpposite Polarities Frequency 5-2500 Hz Preset

One exemplary set of factory default settings retained in the permanentmemory of the generator 14000 can be seen in Table 3 below.

TABLE 3 Factory Default Settings (Retained in Permanent Memory) Minimumcurrent in Formula Level 1 (.2 mA) Mode Calibration level 8^(th) bar outof 16 Therapy duration 15 minutes Intensity Level 10 (2 mA) Ramp upperiod of therapy 15 seconds Therapy duration options 5 to 45 minutes (5minute increments) Countdown to therapy beginning 3 seconds Notificationof completion of 5 seconds therapy Time to hold down ON-OFF for 5seconds powering

With the preceding explanation of the functionality and methods of useof the various systems and processes for delivering electrostimulation,FIGS. 154 through 156 illustrate one exemplary circuit configuration foran electrostimulation delivery device such as the generator 14000. Thecircuit is comprised of various subsets including a power controlcircuit 15410, a voltage regulation circuit 15420, an electrostimulationpulse generation circuit 15510, a microphone circuit 15610, an audiotransceiver circuit 15620, a sensitivity adjustment circuit 15630, and adisplay circuit 15640. Each will be explained in turn along with therelevant connectivity.

In the exemplary embodiment, power is supplied to the entire circuit atthe power control circuit 15410 through a power supply 15412, forexample, a 9V battery. The power button 13630 can be part of the powercontrol circuit 15410, which, when powered on, provides power foroperation of the entire generator 14000. As set forth above, when thecircuit is powered on for the first time, the user needs to set amaximum current to be delivered. This is done with theelectrostimulation pulse generation circuit 15510 in a process alsoreferred to as setting a power threshold. The user can set thisthreshold without knowing what the first-set power would feel like or,as an alternative, the user can place an electrostimulation electrode inthe user's ear canal to experience the level that is being set as thepower threshold. As a baseline, the electrostimulation pulse generationcircuit 15510 sets a level of 2 mA to start this step, which correspondsto level 1 in Table 1. If the user is going to be using music mode, thena headphone jack will have been inserted in the audio in port 14102 ofthe audio transceiver circuit 15620. The audio out port 14103 isconnected to the audio in port 14102 to provide the received audiosignal to speaker assemblies in earbuds of the device coupler. If theuser is going to use ambient mode, then a headphone jack will not bepresent in the audio in port 14102 of the audio transceiver circuit15620 and the received audio signal provided to the speaker assembliesin earbuds of the device coupler will be provided through the microphonecircuit 15610. In either mode, maximum electrostimulation power nowneeds to be adjusted, which entails setting a maximum current amplitude.Setting a maximum current amplitude make sure that the highest level ofaudio input (e.g., loudest notes in music) produce at the electrodes thehighest level of current. Simply put, this level is a ceiling for ahighest dose of electrostimulation and corresponds to a power level inTable 1. The user enters the corresponding level of the maximum currentamplitude into the electrode processor 15512 of the pulse generationcircuit 15510 to confine the electrode processor 15512 during audio modeto not deliver current above this set maximum level. As the user mightbe able to tolerate or want a higher level, this can be increaseddynamically during an electrostimulation session; the user can alsolower the level. For example, if the user selects Level 10 as themaximum current amplitude, then the electrode processor 15512 locks thefloor of the current to Level 1 (corresponding to 0.2 mA) and locks theceiling of the current to Level 10 (corresponding to 2.0 mA).

Now that the maximum current amplitude is set, the user needs to set howoften that maximum current amplitude will arise during a session andthat procedure is accomplished by setting a sensitivity adjustment withthe sensitivity adjustment circuit 15630. If, for example, the userwants the maximum current amplitude to be present very often, thesensitivity will be set higher and, if the user wants the maximumcurrent amplitude to be present infrequently, the sensitivity will beset lower. There exists a problem when listening to a mellow song wherea user can feel particular lows and highs but, if the next song is ametal or EDM song, then the lows and highs will be much different andsecond song with much more frequent highs will clip both medium and hightones to the maximum current amplitude.

There are a few ways to set the sensitivity. As explained above,frequency filters can be used to find peaks at various frequency ranges,e.g., the bass line of a song. However, with music being different inevery song and with ambient sound not necessarily having frequencieswithin such ranges, the inventors discovered that it would be beneficialto set sensitivity using a VU processor to meter the input audio. A VUprocessor produces an average of an overall volume without regard towavelength (e.g., it is wavelength agnostic) and then the output levelof the VU processor is used to modulate the electrostimulation. TheVU-type output is provided with the sensitivity adjustment circuit15630, having its sensitivity circuit 15631 and its audio envelopefollower circuit 15632. A potentiometer of the sensitivity adjustmentcircuit 15630 is set to vary a current provided to the audio envelopefollower circuit 15632. With the sensitivity adjustment circuit 15630,the VU output can be displayed to a user to have the bar graph/needle(FIG. 152/153) bounce/move between the preset low and high levels. Inthe bar graph embodiment, an ideal setting for sensitivity will have theuser sets the level so that the highest bar is rarely activated at thestrongest beat of the song and, in the needle embodiment, an idealsetting for sensitivity will have the user sets the level so that theneedle remains close to the “0” and goes into the red zone rarely andonly at the strongest beat of the song. This manual (analog) setting ofthe sensitivity allows the user to customize the deliveredelectrostimulation throughout the song and to change it for eachdifferent song if desired. It is noted that sensitivity is alsodependent upon the input volume of the signal that enters the audio inport 14102. If the user raises the volume, then the sensitivity can becorrespondingly changed by the user to account for that increase. Thesensitivity can also be done digitally and automatically. In a firstexemplary embodiment, a digital potentiometer can be associated with theprocessor 15512 and be programmed to prevent the bar/needle from goingabove a pre-set or user-set level during any given song and, thereby,adjust the sensitivity on the fly that is also dependent upon the volumeof the audio selected by the user. In a second exemplary embodiment, thedigital potentiometer can be controlled by the processor 15512 to backoff the current level if the maximum current amplitude is being hit toooften within a set amount of time. In another more sophisticatedembodiment, there can be a database of songs with corresponding VU levelprofiles and the processor 15512 can look at the profile of theto-be-played or currently-played song and back off or increase thesensitivity dependent upon both the profile and on the user's selectedvolume. Finally, in a completely dynamic embodiment, the generator 14000can communicate with a song identification application (such asSoundHound® and Shazam®) to identify the next song to be played or theone current playing and, by knowing the song, automatically set thesensitivity based upon a known profile of that song or based upon anon-the-fly analysis of the audio file while, at the same time, take intoaccount the user's volume setting.

Each of the audio signals, either at the microphone 14104 or the audioin port 14102, is amplified and powered 15422 from the output 15422 of avoltage regulator circuit 15420. The resulting output signal is appliedto line 15634, which is an input line to the display processor 15640.This signal is then output from the display processor 15642 as the inputsignal 15514 to the pulse generation circuit 15510, which is the signalthat is pulse modulated by the processor 15512 and output to theelectrode(s) 14101.

The decrease 13642 and increase 13643 buttons and the select button13641 are other input variables to the display processor 15642, therebyenabling control through the display processor 15642. The maximumcurrent amplitude of the electrostimulation signal is controlled throughincrement 15516 and decrement 15517 inputs of the electrode processor15512 from the display processor 15642. With 0.2 mA set as a defaultminimum, therefore, the range of current to be supplied to theelectrodes 14101 from the generator 14000 is set between theuser-selected maximum current and the pre-set minimum current.

As indicated herein, it is important for the generator 14000 to keep theelectrostimulation current where it should be at any given time, i.e.,between the default minimum and the user-selected maximum current, andto not exit out of this range. This is done through the voltageregulation circuit 15420. What could cause an improper amount of currentto be applied to the electrode(s) 14101 is a variability in theresistance of the tissue that is disposed between the two poles of theelectrode 14101. It is known that biological tissue does not have aconstant resistance. Thus, the problem of variable resistivity must beaddressed. There are two aspects to this. First, each person's targettissue does not have the same resistivity and placement of theelectrodes circumferentially within an ear canal, for example, will havedifferent resistance values. Further, the inventors have discovered thattissue changes in resistance when a constant initial current is applied.In most cases the resistance tends to drop as the current is maintained,but resistance can increase, for example when the environment (e.g.,weather) is cold. Simply put, human tissue is a biological resistor, itis not a fixed resistor. So the circuit needs to know how to maintainthe current with an ever-changing resistance. This problem is solvedwith the voltage regulation circuit 15420. During the electrostimulationsession, the voltage regulation circuit 15420 either can sample theresistance at the electrodes or it can measure a current drawn from theoutput of the electrodes and, based upon either (or both) of thesevalues, the voltage regulation circuit 15420 will dynamically constrainthe current and prevent it from going above the user-selected maximumcurrent and the pre-set minimum current to maintain the therapeuticrange and not provide user discomfort. From this it can be said that theelectrostimulation signal (i.e., a neuromodulation electric signal(NES)) is the character of the current that is being delivered to anarea of the body that is in proximity or adjacent to a targeted nerve orother biologic structure (e.g., blood vessel).

With regard to a maximum power level or intensity, the inventorsdiscovered various considerations and one significant one is that a usercan become tolerant of the electrostimulation signal. The problem facingadvancing electronic nerve stimulator devices and methods is whether ornot an individual user can tolerate the discomfort associated with thedelivery of a signal delivered at the power necessary to maximizetherapeutic benefit. The systems and methods herein improve the art byincluding algorithms and processes that prevent a user from becomingtolerant to the electronic signals delivered.

In a first exemplary embodiment, electrostimulation provided by thehereindescribed devices and methods are supplemented by includingauditory stimulation in the form of prerecorded audio, not only bycombining the theory of neurologic distraction, but also by the physicalrelease of endogenous endorphins. Users are provided with the ability tolisten to such prerecorded audio or any other auditory stimulation(e.g., white noise, an audio book, pre-set patterns, and the like)during the electrostimulation therapy. This is enabled because thedevice coupling the electrostimulation electrodes to the user can beconfigured within earbuds or headphones.

In another exemplary embodiment, the generator is provided with amicrophone or similar input device that is able to sense an ambientaudio signal and modulate the electrostimulation signal dependent uponthat ambient audio signal. Of course, this modulation is performedwithin a proscribed therapeutic range as the power varies theelectrostimulation signal in accordance with the ambient audio signal.

With regard to ease of use of the inventive systems and methods, thegenerator is hard-wired, wirelessly connected, or optically connected tothe audio source that is to deliver the audio signal forming themodulation of the electrostimulation.

As set forth herein, continued research will generate a betterunderstanding of neuromodulation progresses. If new and uniqueelectrical signals are discovered to expand uses and effects on thebrain and body of the user of this technology, then users will desire toimplement such signals with the generator. Accordingly, the embodimentof FIG. 156 is supplied with an algorithm delivery circuit 15612 havinga transceiver 15614 allowing an external device to communicate with thegenerator 14000 through the algorithm delivery circuit 15614, forexample, via Bluetooth or Wi-Fi. The algorithm delivery circuit 15612contains all of the circuitry necessary for such communication as wellas a memory to store customized algorithms supplied by the user. Controlof the algorithm delivery circuit 15612 can occur with any of theon-board processors or it can be done through other processors of thegenerator 14000. The algorithms for the formula mode above can also bestored in the memory of the algorithm delivery circuit 15612, forexample. In an exemplary embodiment, to utilize the generator 14000 witheither a pre-set formula or one of the stored algorithms, the algorithmdelivery circuit 15612 can deliver the output signal to be modulatedthrough a switch 15616 that, when set to either the formula mode or analgorithm mode, bypasses the input of the microphone and uses the preampportion of the microphone circuit 15610 to supply the signal to thesensitivity circuit 15620.

In another exemplary embodiment, the audio signal desired by the user(e.g., a particular song) can be pre-converted into anelectrostimulation signal so that the signal is modulated/synchronizedto that song. This signal can then be administered to a user in theabsence of music. This kind of “shadow” synchronization gives the user a“feeling” of the song as an electrical sensation and the ability tomentally “hear” the song even though the user is not actually hearingit. The effect produced is akin to mentally singing or humming a song.This shadow synchronization confers a beneficial signal tolerance byallowing the user to “anticipate” higher doses of electrostimulation(assuming that the user knows the song) because he/she can predict thesignal. This process also confers an audio endorphin release as if thesubject was actually listening to the audio recording. This particularprocess utilizes the theories of ramp-up and pattern following. It isknown that the longer a subject is exposed to a noxious stimulation at aconstant delivery, the tolerance to that noxious stimulation increases.In the inventive “ramp-up” stimulation feature, if the noxiousstimulation increases from a low-level (low power/intensity/current) ofstimulation that is initially tolerated up to an increased level, and isdone so incrementally, then the user can tolerate the higher level andtolerance is increased. This is analogous to the situation of a coldpool getting more comfortable after the initial shock of jumping in. Thesystems and methods herein, therefore, provide a signal deliveringprocess that modulates the power of the signal to have the signalstrength rise progressively and linearly from a well-tolerated, lowpower signal to a progressively increasing power over time, until anasymptote is reached, such that the power stays just below and isrestricted from going above that asymptote.

Delivery of the signal needs not be a constant ramp. It could also beprovided as a sinusoidal increase of the power, with power progressivelyincreasing over time until an asymptote is reached and then decreases toa lower-but-therapeutic level asymptote. The signal can remainsinusoidal or it can rise in amplitude or simply flatten out to a lineartherapeutic level. Any desirable ramping up pattern of increasing to andsubsequently maintaining the ideal target power is also envisioned.

With the theory of “pattern following,” a subject can increase his/hertolerance by experiencing stimulation varying between tolerable andnoxious if it is done in a pattern that is, or ultimately is,predictable by the subject. In other words, if the power of the nervestimulation varies between tolerable and initially noxious within atherapeutic range, but follows a pattern, the subject will tolerate thepeaks in power delivered better, once the subject can anticipate whenthe power will again decrease to lower levels. Over time, the “duration”principle takes effect and the subject becomes able to tolerate thesignal at a constant, high power/high efficacy signal. An example ofthis can be illustrated with waterboarding. If a user was toldbeforehand that his/her head would be forced under water for only fiveseconds, the event would be well tolerated. However, if the same act wasperformed by a stranger who did not indicate what the duration would be,the five-second dunk would be quite poorly tolerated. Putting thediscomfort in an acceptable context allows the brain to anticipate ashorter duration and block out the discomfort when it occurs.

The inventive systems and methods can also be used to counteractseizures caused by epilepsy. It is known that epilepsy can be triggered,such as by a fluorescent light. The systems and methods can beconfigured to detect fluorescent, flashing lights, and/or other lightsknown to cause seizures and, when detected, to administer anelectrostimulation treatment in advance of a seizure.

The inventive systems and methods can also be used to induce aphysiologically beneficial wake up from sleep. It is known to bebeneficial to have elevated cortisol levels when waking in order to havea more pleasant and physically positive waking from sleep. The systemsand methods can be configured to include a wake-facilitation feature. Inparticular, when worn during sleep, the generator can be programmed todeliver electrostimulation at therapeutic levels sufficient to inducecortisol and wake the user up at a particular time. A short time beforewaking (e.g., thirty minutes), the systems and methods slowly develop anelectrostimulation signal to raise the user's cortisol levels and, atwaking time, the cortisol levels will be at a physiologically beneficiallevel. This feature is available particularly with the systems andmethods described and illustrated herein because they are socomfortable. As such, sleeping with the device couplers installed willnot cause or will not impose any measurable defect in a person's sleep.

As set forth above, each of the various neurostimulation devices 1610,2700, 2900, 3200, 3600, 4410, 5200, 5800, 6000, 6200, 6600, 6700, 6900,7100, 7300, 8100, 9500, 9800, 10000, 10400, 11300, 11600, 11900, 12400described herein can be used to treat a number of conditions andailments through stimulation of the vagus nerve. Some of these includedepression, multiple sclerosis, weight loss, motion disorders, insomnia,obesity, and Alzheimer's disease. Importantly, stimulation of the vagusnerve aids in management of pain, in particular, for headaches andmigraines. It is known, however, that, for headaches and migraines,better treatment with neuromodulation occurs at one or more of thefacial artery and the trigeminal nerve.

With knowledge of the above neurostimulation devices, the inventorsdiscovered that securement within the ear canals can be used to exploitthe proximity to both the trigeminal nerve and the facial artery.Accordingly, the above-mentioned headband configuration can be changedto the neurostimulation device 15700 shown in FIGS. 157 to 159. In thisvariation, a C-shaped headband 15702 has distal ends at which anearbud/neurostimulator device can be placed at one or both of the distalends but, in this exemplary embodiment, as will be described in furtherdetail, the focus points for electrical stimulation are the facialartery and the trigeminal nerve and not the vagus nerve (although it isequally possible to include the earbud/neurostimulator device at one ormore of the distal ends in a desirable configuration). At the distalends are ear canal centering devices 15704. When worn, each of thecentering devices 15704 fits into a respective ear canal of a user. Ifthe centering devices 15704 are to double as audio headphones, thenacoustic speakers are present within the centering devices 15704 and aresupplied with signals through a non-illustrated cable. However, mosttherapies for curing headache and migraine pain are associated withquiet and, therefore, the centering device 15704 in this exemplaryembodiment serves to minimize sound, acting as ear plugs but they maycombine the vagus nerve stimulation described herein and combine musicand/or other sounds. The exemplary neurostimulation device 15700 is tobe worn about the back of a user's head, as the embodiment shown in FIG.160. While the neurostimulation device 15700 can be rotated about theaxis between the user's ears to place the headband 15702 under theuser's chin, as will be seen below, that orientation is not asdesirable. As used with the headband embodiment, “rear” is referred toas a position that will be closer to the rear of a user's head when inuse and “front” is referred to as a position that will be closer to theface of a user when in use.

As above, this embodiment of the neurostimulation device 15700 is thatthe headband 15702 is of a material with spring-back properties suchthat, when the C-shape of the headband 15702 is opened to fit on theuser's head, the spring-back of the C-shape provides an inwardlydirected force on the centering devices 15704 to press each into itsrespective ear canal. As above, this headband 15702 is also adjustableto allow a user to increase or decrease the force that the distal endscan place on the user's head. The mechanism for adjusting this force is,however, somewhat different. To adjust this force, a main body 15705defines two cavities that form a spindle holder 15706 and in which aspindle 15708 is disposed. Each of the two ends of the spindle 15708 hasan internally threaded bore into which is threaded a rear end of one oftwo tension cords 15720. The opposing front end of each tension cord15720 is fixed in a respective cord holder 15710 disposed away from thespindle 15706 around the main body 15705 (to approximately the 3 and 9o'clock positions of the C-shaped headband 15702 when viewed from abovea user's head). The threads of the two bores that receive the rear endsof the tension cords 15720 (and the corresponding threads of the rearends of the tension cords 15720) are reversed so that rotation of thespindle 15708 in one direction will pull the two rear ends of thetension cords 15720 together and rotation of the spindle 15708 in theopposite direction will push the two rear ends of the tension cords15720 apart. In this way, as the distal ends of the tension cords 15720are pulled towards one another, a rearwardly directed force is impartedon each of the cord holders 15710 to, thereby, move the two centeringdevices 15704 away from one another and as the distal ends of thetension cords 15720 are pushed away from one another, a forwardlydirected force is imparted on each of the cord holders 15710 to,thereby, move the two centering devices 15704 towards one another.

With such an inward and outward force adjustability of the headband15702, the centering devices 15704 are replaced with centering andforce-imparting booms 15910 that, when placed about a user's head andwithin the ear canals, make possible easy access to either or both ofthe facial artery and the trigeminal nerve. In particular, each boom15910 has a rearward end at which is disposed a centering device 15904that is pointed inwards (i.e., towards a center of the C-shape). Thecentering devices 15904 are shaped to fit within a user's ear canal (asin any of the exemplary embodiments described or shown herein) and actto center the booms 15910 about the user's temples, which is aconsistent location that facilitates placement of electrodes at targetedlocations at or near the trigeminal and/or vagus nerves. This alsoallows the headband embodiments to target the occipital nerves withelectrodes that extend from the inside circumference of a rear portionof the headband 15702 toward the back of the user's head.

The centering device 15904 can be gimbaled (as is illustrated in FIGS.95 to 97) at the rearward end of the boom 15910 to permit the centeringdevice 15904 to accommodate different user's ear canal shapes andangular orientations. Each boom 15910 has a concave extension 15912 thatruns forward from the centering device 15904 to a pivot 15904 thatconnects the boom 15910 to the forward end of the headband 15902 andallows the boom 15910 to pivot at least in the plane of the headband15902 (i.e., the view of FIG. 159). The pivot 15904 can be a gimbal sothat the boom 15910 can pivot in any way at the connection to theforward end of the headband 15902. Forward of the pivot 15904 on theconcave extension 15912 are two structures: a facial artery compressor15914 and a trigeminal nerve stimulator 15916. In the exemplaryembodiment, the facial artery compressor 15914 is the first structureforward of the pivot 15904 and the trigeminal nerve stimulator 15916 isthe second structure even further forward than the facial arterycompressor 15914. The facial artery compressor 15914 is used to placepressure on the facial artery. Accordingly, the inward-most surface thatcontacts the user's skin is hammer shaped, although it can be anyequivalent shape that can compress the facial artery when placedthereagainst. Mechanical compression can be enhanced by addingelectrostimulated compression, which can occur by adding electrodes atthe facial artery compressor 15914 that apply electrical signals havingcharacteristics that impart vasoconstriction. The trigeminal nervestimulator 15916 is used to place an electrical contact at thetrigeminal nerve just forward of the facial artery. Accordingly, theinward-most surface that contacts the user's skin is shaped to besufficiently long enough to contact the user's skin adjacent thetrigeminal nerve when the facial artery compressor 15914 is compressingthe facial artery. Installation of the system is easy, as centeringoccurs on the user's ear canals just as with conventional earphones.

A length of the concave extension 15912 that is rear of the pivot 15904is longer than a length of the concave extension 15912 forward of thepivot 15904. In this way, the pivot 15904 acts as a fulcrum to multiplythe force that the facial artery compressor 15914 will place against thefacial artery. This insures that the trigeminal nerve stimulator 15916contacts the skin and positions the trigeminal nerve stimulatingelectrode 15918 adjacent the trigeminal nerve when the centering device15904 is within the user's ear canals and the headband 15902 is alsoplacing an inwardly directed force on the pivot. In such a state, whichis shown in FIG. 160, there are two forward contact points, one on thefacial artery for either or both of vasoconstriction andneurostimulation and one adjacent the trigeminal nerve forneurostimulation. In particular, the facial artery is mechanicallycompressed bilaterally. With such mechanical processes, the headband15902 can be adjusted to compress the facial artery at a level greaterthan blood pressure. When this occurs, the facial artery occludes andprovides the desired relief. The facial artery compressor 15914 can alsobe fitted with sensing devices to sense characteristics of the temporaryartery. For example, ultrasound, Doppler, and/or impedance sensors canassist with determining efficacy of occlusion and give the user feedbackof such occlusion. With feedback, the user is provided with informationto permit dynamic adjustment of the headband 15902. If electrodes arepresent on the facial artery compressor 15914, then electrical signalscan be applied to the facial artery to electronically collapse theartery.

If the adjustment device of the headband 15902 are motorized (e.g., thespindle 15908), then such sensors can be used to automatically adjustthe compression of the facial artery compressor 15914 as well as thelevel of stimulation being provided by the facial artery compressor15914.

At the same time, stimulation of the trigeminal nerve, which suppliessensation to the head, can take place. It is known that stimulation ofthe trigeminal nerve makes the head numb, thereby, stopping headachesand migraines. One cause of pain for treating headaches and migraineswith prior art devices is due to the discomfort that is associated withmuscular contraction of the forehead. Because the device of FIGS. 157 to160 places pressure at the anterior auricular location, instead offorehead, there is no musculature to contract and, therefore, noresulting discomfort. In this way, the device is able to impart morestimulation with less pain than prior art devices.

Sizing the concave extension 15912 properly places both the facialartery compressor 15914 and the trigeminal nerve stimulator 15916 in adesired position when the centering devices 15904 are within the user'sear canals. Significantly, in such a state, the system can takeadvantage of the location of the centering devices to, for example, alsodeliver audio sound into the ears if speakers are present and/or alsodeliver vagus nerve stimulation into the ear canal or concha if vagusnerve electrodes are present.

The booms of FIGS. 159 and 160 can also be replaced with a gogglesembodiment. Such a configuration can provide both compression andneuromodulation, but in different areas of the head and face. Incontrast to the boom, goggles do not contact the forehead and, instead,are located at orbits of the eye. In such an orientation, the gogglescan be provided with electrodes positioned to stimulate the trochlearnerve.

Electrostimulation with the systems and methods described herein are notlimited to the vagus and trigeminal nerves, even though exemplaryembodiment for these nerves have been provided. Other exemplary areasfor treatment are mentioned herein and can also include transcutaneousstimulation of peripheral, cranial, or central nervous system targetlocations. An example of the latter is the spinal cord. In such a case,novel aspects of the systems and methods herein are applicable and, forexample, transcutaneous stimulation of a certain area of the spinal cordwill be different for persons that have more fat than others. This wouldpresent a higher impedance than someone who is thin and, therefore, theautomatic current control circuit with voltage adjustment resolves anyissue with a person receiving current to the target structure thatdifferent from another.

The embodiments herein are described as treating pain, such as headachesand migraines. However, the devices and methods can also be used totreat shingles, trigeminal neuralgia. TMJ dysfunction, and atypicalfacial pain (e.g., after dental procedures).

Described herein are various earbud embodiments for theelectrostimulation device coupler. These configurations are not intendedto be limited to such embodiments and include additional exemplaryembodiments for the earbuds in FIGS. 161 through 168. In the embodimentof FIGS. 161 to 164, the outer surface between the audio output end andthe distal end of the channels between adjacent petals is enlarged,thereby providing a distal surface extent 16110. In comparison, theembodiment of FIGS. 165 to 168, there is an intermediate radial wall16510 within the channels that are defined by adjacent petals. Alsoshown in these and the previous embodiments of the earbuds are exemplaryprolate spheroid shapes. The inventors have discovered that a shape ofthe outer surface of the prolate spheroid earbuds can improveconnectivity between the conductive outer surfaces of the earbuds andthe target tissue of the ear canal. It is noted that users havedifferent ear canal shapes and sizes. Accordingly, the followingformulas were derived to dictate a curvature of the outer surface of theearbud form for various sizes of the patient coupler. These formulasvary based upon the maximum or “terminal diameter” of the various sizedearbuds. These formulas plot a longitudinal curvature of the outersurface of the terminal diameters as listed below. Therefore, majordiameters not listed would use the formula listed below that is closestto the major diameters listed. The earbud outer surface longitudinalcurvature derived from the following formulas provide the best contactof electrodes to the skin surface and provide proper fit to varying earcanal anatomies and diameters. In the formulas below, the earbud profilepolynomials are for a controlled 8.0 mm length with an 11.00 mm overalllength.

Size: Small

Equation: −(0.0031x³)+(0.0024x²)−(0.0178x)+4.1852

Domain: x0=0 & xf=8.00

Major Diameter=8.37 mm/8.3704 mm

Size: Intermediate 1

Equation: −(0.0034x³)−(0.0066x²)−(0.0016x)+4.7888

Domain: x0=0 & xf=8.00

Major Diameter=9.58 mm/9.5776 mm

Size: Medium

Equation: −(0.0004x⁴)+(0.0008x³)−(0.0191x²)−(0.0621x)+5.3912

Domain: x0=0.50 & xf=8.00

Major Diameter=10.72 mm/10.7824 mm

Size: Intermediate 2

Equation: −(0.001x⁴)+(0.0118x³)−(0.0787x²)−(0.0037x)+5.9404

Domain: x0=0.00 & xf=8.00

Major Diameter=11.88 mm/11.8808 mm

Size: Large

Equation: −(0.0071x³)+(0.00009x²)−(0.0295x)+6.4818

Domain: x0=0 & xf=8.00

Major Diameter=12.96 mm/12.9636 mm

In the above, the Y-intercept (where x=0) represents (in millimeters)the radius of the major diameter of the earbud. These exemplary earbudshave a 3.0 mm taper section for domain x=−3.0 to 0.

Various different features can be added to the embodiments of the devicecouplers (e.g., helix cuffs and ear buds) described herein. For example,the device couplers at the user's ears can be partially or completelyilluminated. Illumination can backlight a product logo, can be pulsedwith respect to therapeutic pulses, can be pulsed with respect to audioemanating from a coupled audio device such as an earbud, can be pulsedwith respect to audio emanating from the environment in which the useris using the device, and/or can be pulsed with respect to control froman external source, such as from a DJ in a night club.

It is noted that various individual features of the inventive processesand systems may be described only in one exemplary embodiment herein.The particular choice for description herein with regard to a singleexemplary embodiment is not to be taken as a limitation that theparticular feature is only applicable to the embodiment in which it isdescribed. All features described herein are equally applicable to,additive, or interchangeable with any or all of the other exemplaryembodiments described herein and in any combination or grouping orarrangement. In particular, use of a single reference numeral herein toillustrate, define, or describe a particular feature does not mean thatthe feature cannot be associated or equated to another feature inanother drawing figure or description. Further, where two or morereference numerals are used in the figures or in the drawings, thisshould not be construed as being limited to only those embodiments orfeatures, they are equally applicable to similar features or not areference numeral is used or another reference numeral is omitted.

The electrical combinations of ground/positive and positive/negative areused in various places herein. These various alternatives are not to beconsidered as limiting the described embodiment to one or the other ineach case and are to be taken as equally interchangeable wherever usedherein.

For the purposes of the description, a phrase in the form “A/B” or inthe form “A and/or B” or in the form “at least one of A and B” means(A), (B), or (A and B), where A and B are variables indicating aparticular object or attribute. When used, this phrase is intended toand is hereby defined as a choice of A or B or both A and B, which issimilar to the phrase “and/or”. Where more than two variables arepresent in such a phrase, this phrase is hereby defined as includingonly one of the variables, any one of the variables, any combination ofany of the variables, and all of the variables, for example, a phrase inthe form “at least one of A, B, and C” means (A), (B), (C), (A and B),(A and C), (B and C), or (A, B and C).

The foregoing description and accompanying drawings illustrate theprinciples, exemplary embodiments, and modes of operation of theinvention. However, the invention should not be construed as beinglimited to the particular embodiments discussed above. Additionalvariations of the embodiments discussed above will be appreciated bythose skilled in the art and the above-described embodiments should beregarded as illustrative rather than restrictive. Accordingly, it shouldbe appreciated that variations to those embodiments can be made by thoseskilled in the art without departing from the scope of the invention asdefined by the following claims.

What is claimed is:
 1. An electrostimulation device, comprising: anelectrode coupler comprising an earbud; the earbud shaped to form fitinside an ear canal of a human ear; and the earbud composed of a pliablematerial that conforms to the ear canal when inserted therein, thepliable material forming at least two electrostimulation electrodes eachelectrostimulation electrode conductively connected to a conductive leadadapted to receive a nerve electrostimulation signal; and the earbudadapted to transmit the nerve electrostimulation signal through theelectrostimulation electrodes from the conductive leads to tissue withinthe ear canal when disposed therein.
 2. The electrostimulation deviceaccording to claim 1, further comprising: a speaker assembly disposedwithin the earbud, the speaker assembly adapted to receive a musicsignal and to output music into the ear canal of a human ear; and aspeaker conduit conductively connected to the speaker assembly andhaving a standard audio jack shaped to be inserted into a standard audiooutput of a music source to receive the music signal.
 3. Theelectrostimulation device according to claim 2, wherein the music signalis one of: a recorded music signal; a transmitted music signal; and anambient signal obtained from the environment surrounding theelectrostimulation device.
 4. The electrostimulation device according toclaim 2, wherein the nerve electrostimulation signal is modulated by themusic signal.
 5. The electrostimulation device according to claim 2,wherein the music source is also the source of the nerveelectrostimulation signal.
 6. The electrostimulation device according toclaim 2, wherein the music source is different from the source of thenerve electrostimulation signal.
 7. The electrostimulation deviceaccording to claim 1, further comprising: a speaker assembly disposedwithin the earbud, the speaker assembly adapted to receive a musicsignal and to output music into the ear canal of a human ear; and areceiver adapted to wirelessly receive a music signal from a wirelessmusic source and to output the music signal to the speaker.
 8. Theelectrostimulation device according to claim 7, wherein the music signalis one of: a recorded music signal; a transmitted music signal; and anambient signal obtained from the environment surrounding theelectrostimulation device.
 9. The electrostimulation device according toclaim 7, wherein the nerve electrostimulation signal is modulated by themusic signal.
 10. The electrostimulation device according to claim 7,wherein the music source is also the source of the nerveelectrostimulation signal.
 11. The electrostimulation device accordingto claim 7, wherein the music source is different from the source of thenerve electrostimulation signal.